ulrich medical tezo titanium cage Series User manual

WS 3495-eIFU
R6.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
1
Thisdocument is valid onlyon the dateprinted.Ifunsureof the print date,re-print to ensure use of the latestversionof the IFU.Theonusresideswith
the user to ensure that the most up-to-date IFU is used.
Gebrauchsanweisung
Instructions for use
Instructions for use
Instructions for use
Mode d’emploi
Istruzioni per l'uso
Instrucciones de uso
Instruções de utilização
Brugsanvisning
Bruksanvisning
Käyttöohje
Kullanım Kılavuzu
Οδηγίε χρήση
Gebruiksaanwijzing
Bruksanvisning
  
Instruciunile de utilizare
  
Návod k použití
Lietošanas instrukcija
Instrukcja obsługi
Návod na použitie
Navodila za uporabo
󻸛󼐘󾖴󻺓󻟴󻺋
使用说明
tezo™ titanium cage family
Deutsch 2
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2019-07-02

WS 3495-eIFU
R6.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
2
Thisdocument is valid onlyon the dateprinted.Ifunsureof the print date,re-print to ensure use of the latestversionof the IFU.Theonusresideswith
the user to ensure that the most up-to-date IFU is used.
SYSTEM: tezo™ titanium cage family
SPRACHE: Deutsch Für Benutzer in USA gilt ausschließlich die spezielle Version für das Land USA.
Für Benutzer in Kanada gilt ausschließlich die spezielle Version für das Land Kanada.
Alle Anweisungen aufmerksam lesen. Ein Missachten der Anweisungen, Warnhinweise und Vorsichts-
maßnahmen kann zu schweren Folgen oder Verletzungen beim Patienten führen.
Vor der klinischen Anwendung alle Produktmaterialien sorgfältig beachten.
Die als Gesamtdokumentation zum System bereitgestellten notwendigen Produktmaterialien sind:
Systembezogene Gebrauchsanweisung, OP-Technik und ggf. Supplements, Montage- und Demonta-
geanleitungen sowie das„Aufbereitungshandbuch Implantate und Instrumente“ UH 1100.
1 Bestimmungsgemäßer Gebrauch
tezo ist eine Implantatgruppe – bestehend aus tezo-P, tezo-T, tezo-A – zur Abstützung des Zwischenwirbelraumes im Bereich der menschli-
chenlumbalen und lumbosakralenWirbelsäulemit demZiel der UnterstützungderknöchernenFusionderWirbelkörper. tezowirdeinzelnoder
paarweise zwischen zwei Wirbelkörper eingebracht. Die Implantate können zugleich zur Wiederherstellung des Wirbelsäulenprols dienen.
Um eine Fusion zu erreichen, sollte das Implantat immer zusammen mit Knochen oder Knochenersatzmaterial in den Zwischenwirbelraum
eingebracht werden. Die zusätzliche stabilisierende Instrumentierung zum Beispiel mit einem Pedikelschrauben-Stab-System ist erforderlich.
2 Produktbeschreibung
tezo sind Implantate zur lumbosakralen intersomatischen Fusion. Es kann die ALIF-Technik (Anterior Lumbar Interbody Fusion), PLIF-Technik
(Posterior Lumbar Interbody Fusion) oder TLIF-Technik (Transforaminal Lumbar Interbody Fusion) verwendet werden. Die Cages dienen der
Überbrückung und Stabilisierung des Zwischenwirbelraumes mit dem Ziel der Unterstützung der knöchernen Fusion. Die Rekonstruktion des
Wirbelsäulenprols wird u. a. durch Größe, Höhe und Winkelung der Cages erreicht. Die Cages sind mit Knochen/Knochenersatzmaterial be-
füllbar und bieten einen optimalen Durchbauungsraum.
3 Indikationen
Fusionsoperationen sind z. B. indiziert für:
Patienten mitWirbelsäule assoziierten Infektionen (z. B. Spondylodiszitis)
Degenerative Bandscheibenerkrankung
Postdiskektomiesyndrom
Revision nach Bandscheibenoperation
Degenerative Instabilität
Lytische Spondylolisthese
Kongenitale Fehlstellung, z. B. Skoliose
Spinalstenose mit klinischer Instabilität
Pseudarthrose
4 Kontraindikationen
Patienten mit Fieber oder Leukozytose
Patienten mit nachgewiesener Materialallergie oder Neigung zu Fremdkörperreaktionen
Patienten mit einem ungünstigen medizinischen oder psychologischen Allgemeinzustand, der durch den Eingri weiter verschlechtert
werden könnte; bei diesen Patienten ist eine sorgfältige Abwägung durch den behandelnden Chirurg/Arzt vorzunehmen
Patienten mit unzureichender Knochenqualität oder -quantität, z. B. schwere Osteoporose, Osteopenie, Osteomyelitis
Schwangerschaft
5 Mögliche Nebenwirkungen
Mögliche Komplikationen, die mit dem Implantat einhergehen können sind:
Implantatlockerung, -dislokation und/oder Implantatversagen
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Lokale oder systemische Reaktionen auf Grund einer Materialunverträglichkeit
Ausbleiben der knöchernen Fusion
Anschlussdegeneration von Nachbarsegmenten
Diese möglichen Komplikationen können weitere operative Eingrie (Implantatentfernung oder Erneuerung der Stabilisierung) zur Folge
haben. Sonstige Komplikationen, die durch das operative Verfahren an sich und unabhängig vom Implantat entstehen können, sind:
Allgemeine operationsbedingte Gefahren und Komplikationen
Narkoserisiken, Bluttransfusionsrisiken, Lagerungsschäden
Lungenkomplikationen
Infektion
Wundheilungsstörung
Kardiovaskuläre Komplikationen wie z. B. Blutverlust,Thrombose, Embolie, Gerinnungsstörung
Gastrointestinale Komplikationen wie z. B. Gastritis, Ileus, Ulcus
Neurologische Komplikationen wie z. B. Rückenmarks- oder Nervenwurzelläsionen mit vorübergehenden oder bleibenden sensorischen
und/oder motorischen Beeinträchtigungen (Blasen- und Mastdarmstörungen, Sexualfunktionsstörungen)
Intraoperative Verletzung von Gefäßen, Massenblutung, Hirnschlag, Hirnblutung mit potentiell lebensbedrohlichen Folgen
Verletzung von Nachbarorganen der Wirbelsäule wie Halseingeweide, Brust- und Bauchorgane je nach operierter Region
6 Warnhinweise und Vorsichtsmaßnahmen
6.1 Allgemein
Der Anwender muss sicherstellen, dass die aktuellenVersionen der als Gesamtdokumentation zum System bereitgestellten vollständigen
Produktmaterialien vorliegen und berücksichtigt werden. Diese sind zudem verfügbar unter: www.ifu.ulrichmedical.com. Auf Anfrage
kann ein gedrucktes Exemplar innerhalb von 7Tagen geliefert werden.
Dieses Produkt darf nur von einem in der Wirbelsäulenchirurgie erfahrenen Arzt unter sterilen Bedingungen in einem Operationssaal mit
Bildwandler verwendet werden.
Der behandelnde Arzt trägt die Verantwortung für die richtige Auswahl der Patienten, das erforderliche Training mit dem System und die
Erfahrung bei der Auswahl und Platzierung von Implantaten. Ihm obliegt auch die Entscheidung, Implantate postoperativ zu belassen
oder wieder zu entfernen.
Das Produkt muss sorgfältig gehandhabt und gelagert werden. Implantate, die Beschädigungen oder Kratzer aufweisen, dürfen nicht
verwendet werden, da die Festigkeit und Ermüdungsresistenz beeinträchtigt sein können.
Implantate der entsprechenden ulrich medical Systeme sind ausschließlich mit den dafür vorgesehenen systemspezischen Instrumenten
zu verwenden, sofern nicht anderweitig angegeben.
Die Verbindung von ulrich medical Implantaten mit Implantatkomponenten anderer Hersteller ist nicht zulässig. Eine Kombination mit
anderen Implantaten von ulrich medical ist nicht zulässig.
Korrosion von Metallimplantaten ist aufgrund vorhandener Passivschichten sehr gering, kann jedoch zur beschleunigten
Materialermüdung mit der Möglichkeit eines Materialbruches sowie zur Zunahme der in den Körper abgegebenen Metallbestandteile
führen. Korrosion wird begünstigt durch die Berührung von Komponenten aus unterschiedlichen Metallen sowie durch eine Beschädigung
der Implantatoberäche. Ein direkter Kontakt mit Metallimplantaten anderer Hersteller ist nicht zulässig.
6.2 Präoperativ
Eine Implantation ist erst dann in Betracht zu ziehen, wenn alle anderen Behandlungsmöglichkeiten sorgfältig abgewogen und nicht
als besser erkannt worden sind. Selbst ein erfolgreich implantiertes Implantat ist dem oder den gesunden Bewegungselement(en)
der Wirbelsäule unterlegen. Umgekehrt kann ein Implantat für den Patienten ein vorteilhafter Ersatz für ein oder mehrere schwer
veränderte(s), degenerierte(s) Bewegungselement(e) sein, weil damit Schmerzen beseitigt und eine guteTragfähigkeit erreicht werden
kann.
Der Anwender muss beim Einsatz in einer nicht ausgewachsenen Wirbelsäule sorgfältig den Nutzen gegenüber dem Risiko abwägen.
Der Patient ist über die Risiken des Eingris und des Implantateinsatzes, einschließlich gegebenenfalls notwendiger Revisionen,
eingehend aufzuklären.
Der behandelnde Arzt sollte das mit der Verwendung dieses Implantats zu erwartende Operationsresultat, insbesondere hinsichtlich
möglicher physikalischer Limitationen des Implantats, mit dem Patienten ausführlich besprechen. Der postoperative Aktivitätsgrad
beeinusst die Lebensdauer des Implantats und die Haltbarkeit des Implantats im Knochen. Der Patient muss daher auf Einschränkungen
und Gefahren bei täglichen Aktivitäten und auf besondere Verhaltensregeln hingewiesen werden. Rauchen kann fusionshemmend
wirken und Promotor für eine erhöhte Rate von Pseudarthrose sein. Patienten sollten über die möglichen negativen Auswirkungen
des Rauchens auf den Behandlungserfolg einer Fusionsoperation aufgeklärt werden. Der behandelnde Arzt muss abschätzen, ob der
Patient die Anordnungen verstehen und befolgen kann. Besondere Aufmerksamkeit sollte auf eine postoperative Besprechung und die
Notwendigkeit regelmäßiger medizinischer Kontrollen gelegt werden.
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Die korrekte Implantatwahl und -platzierung ist durch den prä-, intra- und postoperativen Einsatz geeigneter diagnostischer Verfahren
sicherzustellen bzw. zu überprüfen.
Fehler in der Auswahl des Implantats können zu vorzeitigem klinischen Implantatversagen führen. Die Anzahl der zu versorgenden
Segmente ist sorgfältig zu bestimmen. Der menschliche Knochen beschränkt durch seine Form und Beschaenheit die Größe und
Widerstandsfähigkeit des Implantats.
6.3 Intraoperativ
Das Implantat wird steril geliefert und darf nicht resterilisiert werden.
Das Implantat nicht verwenden, wenn dieVerpackung beschädigt ist oder außerhalb des sterilen Bereichs geönet wurde.
Das Implantat nicht verwenden, wenn das Haltbarkeitsdatum abgelaufen ist.
Aseptische Techniken verwenden, um eine Kontamination während der Entnahme des Implantats aus der Sterilverpackung und bei der
Anwendung des Implantats zu vermeiden.
tezo-P Implantate sind ausschließlich für den paarweisen Einsatz im Bandscheibenfach vorgesehen.
Nachdem das Implantat Kontakt mit einem Patienten hatte, verschmutzt oder eingesetzt wurde, darf es nicht wiederverwendet
werden und muss entsorgt werden. Selbst wenn das Implantat äußerlich unverändert erscheint, können vorangegangene Belastungen
Beschädigungen verursacht haben, die zu einem Implantatversagen führen können.
Umeine Fusion zu erreichen,solltedasImplantatimmer zusammen mitKnochen oder Knochenersatzmaterialin den Zwischenwirbelraum
eingebracht werden.
6.4 Postoperativ
Der Patientsollteangewiesen werden,seinen behandelnden Arzt unverzüglich über ungewöhnlicheVeränderungenim Operationsbereich
zu informieren.
Der Patient soll überwacht werden, falls eine Veränderung im instrumentierten Bereich aufgefallen ist. Der behandelnde Arzt soll die
Möglichkeit eines klinischen Implantatversagens bewerten und mit dem Patienten die erforderlichen Maßnahmen besprechen, die zur
weiteren Heilung beitragen.
Das eingesetzte Implantat dient der Rekonstruktion von Substanzdefekten innerhalb der Operationsstelle während eines maximal
2-jährigen Heilungsprozesses. Nachdem die Operationsstelle fusioniert ist, ist das Implantat fest im Knochen verankert. Das Implantat
ist daher nicht zur Entfernung vorgesehen, außer es treten Komplikationen, ein Implantatversagen oder eine verzögerte Heilungsphase
(keine Fusion innerhalb von 2 Jahren) auf, die eine Implantatentfernung erforderlich machen. Die Entscheidung darüber sollte aber erst
nach sorgfältiger fachärztlicher Abwägung bezüglich des Risikos gegenüber dem Nutzen durchgeführt werden.
Durch dasVorhandensein des Implantats im Körper können folgende Komplikationen auftreten:
1. Korrosion, mit lokaler Gewebeentzündung oder Schmerzen
2. Migration des Implantats, möglicherweise resultierend inVerletzungen
3. Risiko von zusätzlichenVerletzungen verursacht durch ein postoperatives Trauma
4. Verbiegungen, Lockerungen oder Brüche
5. Schmerzen, Beschwerden oder ungewöhnliche Empndlichkeit aufgrund des Vorhandenseins des Implantats
6. Risiko der Infektion oder Entzündung
7. Knochenschwund aufgrund von Stress Shielding
8. Potentiell unbekannte oder unerwartete Langzeiteekte
Eine verzögerte Heilungsphase, eine nicht erfolgte Knochenfusion, auftretende Knochenresorption oder ein Trauma können das Implantat
nach der Implantation übermäßig belasten und zu Implantatversagen führen.
Ein Implantatversagen ist auch nach erfolgreicher Fusion möglich.
Die Implantatentfernung muss entsprechend nachversorgt werden.
Explantierte Implantate dürfen nicht wiederverwendet werden.
Der Patient sollte über die nach der Implantation notwendigen Verhaltensanweisungen, einschließlich der Maßnahmen, die bei einem
Vorkommnis mit dem Implantat zu treen sind, aufgeklärt werden. Ein Implantatpass ist dem Patienten auszuhändigen.
7 Empfohlene Anwendung
Die weitergehende Beschreibung der Anwendung von tezo ist in der alsTeil der Gesamtdokumentation zum System bereitgestellten OP-Tech-
nik enthalten und zudem verfügbar unter www.ifu.ulrichmedical.com.
8 Materialinformation
Die tezo Implantate sind aus einer Titanlegierung gemäß ISO 5832-3 und ASTM F136 hergestellt. Die Produkte sind gemäß EN ISO 10993-1
biokompatibel, korrosionsbeständig und nicht toxisch im vorgesehenen Anwendungszweck.
9 MRT Information MR
ulrich medical tezo Implantate sind als„MR conditional“ gemäß Norm ASTM F2503 eingestuft.
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Die„MR conditional” Komponenten wurden nach den ASTM Normen: F2052; F2182; F2213 und F2119 getestet. Ein Patient mit einem tezo
Implantat kann unter folgenden Bedingungen im MRT untersucht werden:
Feldstärken von 1,5 T und 3,0 T
höchster Feldgradient von 30T/m (3000 G/cm) oder weniger
maximale spezische Absorptionsrate (SAR) von 2 W/kg für den Normal Operating Mode für eine Scanzeit von 30 Minuten oder 4W/kg für
den First Level Controlled Mode für eine Scanzeit von 15 Minuten
Hinweis: Im experimentellen Test wurde eine maximale Erwärmung von 6,0°C gemessen bei:
1,5 T und 3,0T
15 Minuten Scanzeit
SAR 4W/kg
Unter diesen Scanbedingungen kann ein Patient risikoarm untersucht werden. Um die Erwärmung gering zu halten, sollte die Scanzeit so kurz
wie möglich und die SAR so gering wie möglich gehalten werden.
Artefakte: Die MR Bildgebung im Bereich der Implantate kann durch Artefakte gestört werden. Im experimentellen Test ergaben sich Arte-
fakte bis zu 22 mm radial um das Implantat.
Die Scans wurden mit folgenden Parametern durchgeführt:
FFE Sequenz: TR 100 ms, TE 15 ms, ip angle 30°
SE Sequenz: TR 500 ms, TE 20 ms, ip angle 70°
Die SE Sequenz zeigt reduzierte Artefakte (≤ 10 mm).
Eine sorgfältige Risiko-/Nutzenbewertung ist durch den behandelnden Arzt vorzunehmen.
10 Verpackung und Lagerung
Das Produkt wird steril geliefert. Die Sterilität bleibt gewährleistet, solange die Verpackung nicht geönet oder beschädigt ist und das Halt-
barkeitsdatum nicht überschritten ist. Das Produkt muss bis zur Verwendung trocken gelagert werden.
InstrumentekönnenbeiLagerung unter ungünstigen Bedingungen korrodieren.Um dies zu vermeiden,sind diese trockenundstaubgeschützt
zu lagern. Damit sich auf den Instrumenten keine Feuchtigkeit (Kondensat) bildet, sind größere Temperaturschwankungen zu vermeiden.
Chemikalien können im direkten Kontakt Metall zerstören oder Dämpfe abgeben, die korrosiv wirken. Instrumente dürfen daher nicht zusam-
men mit Chemikalien gelagert werden.
Für die Lagerung der Instrumente sind die zum System gehörenden Lagerungssiebe zu verwenden.
11 Identikation und Rückverfolgbarkeit
Implantate sind mit Artikel- und Lotnummer auf dem Verpackungslabel und, soweit technisch machbar, auf dem Implantat selbst gekenn-
zeichnet.
Um die Rückverfolgbarkeit zu gewährleisten, müssen diese Daten entsprechend in der Klinik dokumentiert werden. Bei steril verpackten
Implantaten sind entsprechende Aufkleber zur Dokumentation enthalten.
12 Entsorgung gebrauchter Produkte
Zur Entsorgung von gebrauchten Medizinprodukten beachten Sie bitte die länderspezischen Regelungen zur Entsorgung von Klinikmüll.
13 Reinigung, Desinfektion und Sterilisation
Wiederverwendbarkeit von tezo Implantaten:
Die Implantate werden steril ausgeliefert und dürfen nicht aufbereitet oder resterilisiert werden. Die erneute Aufbereitung kann zu Material-
schädigungen führen, die die Funktion beeinträchtigen können.
Für die Reinigung, Desinfektion und Sterilisation von unsterilen Instrumenten ist das in der Gesamtdokumentation zum System bereitgestellte
„Aufbereitungshandbuch Implantate und Instrumente“ UH 1100 zu verwenden. Für einzelne Instrumente, die in der systembezogenen OP-
Technik entsprechend markiert sind, müssen die in der Gesamtdokumentation zum System bereitgestellten„Montage- und Demontageanlei-
tungen mit speziellen Reinigungshinweisen“ beachtet werden.
Diese sind zudem verfügbar unter: www.ifu.ulrichmedical.com.
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14 Kennzeichnung und Symbole
Artikelnummer Fertigungslosnummer, Charge Menge
Hersteller Herstellungsdatum Verwendbar bis
Bei beschädigter Verpackung
nicht verwenden Nicht wiederverwenden Strahlensterilisiert
Achtung: Gemäss US-Bundesgesetz darf dieses Produkt nur an Ärzte oder auf
deren Anordnung verkauft werden Achtung
Montage- und Demontageanleitung mit speziellen Reinigungshinweisen
beachten Gebrauchsanweisung beachten
CE-Kennzeichnung mit Identikationsnummer der Benannten Stelle Nicht steril
MR
Bedingt MR sicher – ein Produkt, das unter spezizierten Auagen keine wissentlichen Gefährdungen im spezischen
MR-Umfeld aufzeigt
NON
STERILE
2019-07-02

WS 3495-eIFU
R6.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
7
Thisdocument is valid onlyon the dateprinted.Ifunsureof the print date,re-print to ensure use of the latestversionof the IFU.Theonusresideswith
the user to ensure that the most up-to-date IFU is used.
SYSTEM: tezo™ titanium cage family
LANGUAGE: English The only version applicable to users in the U.S. is the version intended especially for the United States.
The only version applicable to users in Canada is the version intended especially for Canada.
Read all instructions carefully. Failure to follow instructions, warnings and precautionary measures
may have severe consequences or result in patient injury.
Take into careful consideration all product materials before clinical use.
The required product materials prepared as overall documentation of the system are: system related
instructions for use, surgical technique and, if applicable, supplements, assembly and disassembly
instructions, as well as "Processing manual implants and instruments" UH1100.
1 Intended use
tezo is an implant group – consisting of tezo-P, tezo-T, tezo-A – for support of the intervertebral space in the lumbar and lumbosacral spine
in humans with the purpose of supporting bone fusion of the vertebral bodies. tezo is inserted individually or in pairs between two vertebral
bodies. The implants can also serve as a means of restoring the spinal prole.To achieve fusion, the implant should always be inserted with
bone or bone graft material into the intervertebral space. Additional stabilizing instrumentation is necessary, for example, with a pedicle
screw-rod system.
2 Product description
tezo are implants for lumbosacral interbody fusion. The ALIF technique (Anterior Lumbar Interbody Fusion), the PLIF technique (Posterior
Lumbar Interbody Fusion) or the TLIF technique (Transforaminal Lumbar Interbody Fusion) can be used. The cages can be used for bridging and
stabilizing the intervertebral space with the purpose of supporting bony fusion. The reconstruction of the spinal prole is achieved through
the size, height, and angulation of the cages, among others. The cages are to be lled with bone/bone graft material and provide optimal
space for bony fusion.
3 Indications
Indications for fusion procedures are for example:
Patients with infections associated with the spine (e.g. spondylodiscitis)
Degenerative disk disease
Post-diskectomy syndrome
Revision following disk surgery
Degenerative instability
Lytic spondylolisthesis
Congenital malposition such as scoliosis
Spinal stenosis with clinical instability
Pseudarthrosis
4 Contraindications
Patients with fever or leukocytosis
Patients with a history of material allergy or patients who tend to react to foreign bodies
Patientswhosegeneralmedical or psychological condition is unfavorablefor-or could be worsened by the procedure;carefulconsideration
is required on the part of the treating physician/surgeon for these patients
Patients with inadequate bone quality or quantity (e.g. severe osteoporosis, osteopenia, osteomyelitis)
Pregnancy
5 Possible side eects
Possible complications associated with the implant are:
Implant loosening, dislocation and/or implant failure
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Local or systemic reactions due to material intolerance
Failure of bony fusion
Adjacent segment degeneration
These possible complications may lead to further surgical interventions (implant removal or stabilization renewal). Other complications which
may be caused by the surgical procedure itself and independent of the implant are:
General surgical risks and complications
Anesthesia and blood transfusion risks as well as positioning damage
Lung complications
Infection
Wound healing disorders
Cardiovascular complications, such as blood loss, thrombosis, embolism, coagulopathy
Gastrointestinal complications, such as gastritis, ileus, ulcer
Neurological complications, such as spinal cord or neural root lesions with temporary or permanent sensory and/or motor disturbances
(bladder and rectal disorders, sexual dysfunction)
Intraoperative injury to blood vessels, massive hemorrhage, stroke, cerebral hemorrhage with potential life-threatening consequences
Injury to organs adjacent to the spine, such as cervical, thoracic and abdominal organs, depending on the region operated on
6 Warnings and precautions
6.1 General
The user has to ensure that the most current versions of the complete product materials provided as overall documentation of the system
are on hand and considered. These are also available at: www.ifu.ulrichmedical.com. A printed copy may be delivered within 7 days,
upon request.
This product must be used only by an experienced spine surgeon, under sterile conditions and in an operating room where C-arm is
available.
The treating physician is responsible for making the proper selection of patients, and for acquiring the training with the system and
experience required for implant selection and placement.The treating physician is also responsible for determining whether to leave the
implant following surgery or to remove it.
The product must be carefully handled and stored. Implants with any kind of damage or scratches must not be used, as product stability
and resistance to fatigue may be aected.
Implants of the corresponding ulrich medical systems must be used exclusively with the system-specic instruments intended for this
purpose, unless otherwise indicated.
Connecting ulrich medical implants to implant components of other manufacturers is not permitted. A combination with other implants
from ulrich medical is not permitted.
Given the presence of passive layers, corrosion of metal implants is very minimal. Nevertheless, there may be accelerated material fatigue
and the possibility of a break, as well as increased release of metal components in the body. Corrosion is promoted by the components
made of dierent metals coming into contact and by damage to the implant’s surface. Direct contact with metal implants from other
manufacturers is not allowed.
6.2 Preoperative
Implantationshould only beconsideredwhen all other treatment options have been carefullyweighed and ruledout. A successfulimplant
is also inferior to the healthy moving element(s) of the spine. On the other hand, an implant may be an ecient replacement of one or
more severely deformed or degenerated moving elements in order to eliminate pain and achieve good load bearing capacity.
The user must carefully weigh the benets against the risks when using it in a non-mature spine.
The risks of the procedure and the use of the implant, including any revisions which may be necessary, should be explained to the patient
in detail.
The treating physician should conduct with the patient a detailed discussion of the surgical results that may be anticipated, particularly
with regard to potential physical limitations of the implant. The degree of postoperative activity aects the life time of the implant and
the stability of the implant in the bone. Thus, the patient must be informed of the limitations and risks inherent in daily activities and
made aware of special guidelines for movement. Smoking can inhibit fusion and may predispose to an increased rate of pseudoarthrosis.
Patients should be informed about the possible negative eects of smoking on the success of a fusion procedure. The treating physician
must assess whether the patient can understand and follow such instructions. Special attention should be given to postoperative
discussion and the need for regular medical monitoring.
Ensure that suitable pre-, intra- and postoperative diagnostic procedures are performed to evaluate and ensure proper implant selection
and placement.
Errors in implant selection could result in premature clinical implant failure. The number of segments to be treated must be accurately
determined.The shape and composition of human bones limits the size and durability of the implant.
2019-07-02

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6.3 Intraoperative
The implant is delivered sterile and must not be resterilized.
Do not use the implant if the packaging is damaged or was opened outside the sterile area.
Do not use the implant if the expiry date has passed.
Use aseptic techniques in order to avoid contamination when taking the implant out of the sterile packaging and when using the implant.
tezo-P implants are intended exclusively for use in pairs in the intervertebral space.
After the implant has been in contact with a patient, has been soiled or used, it must not be reused and must be discarded. Even if the
exterior of the implant appears unchanged, prior stress may have caused damage that can lead to implant failure.
To achieve fusion, the implant should always be inserted into the intervertebral space with bone or bone graft material.
6.4 Postoperative
The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where
the surgery was performed.
The patient should be monitored for any changes to the implant area. The treating physician should assess the potential for clinical
implant failure and discuss with the patient the necessary measures to promote further healing.
The inserted implant serves to reconstruct substance defects of the surgical site over a maximum two-year healing process. After the
surgical site is fused, the implant is rmly anchored in the bone. The implant is therefore not intended to be removed unless there are
complications, implant failure, or a delayed healing phase (no fusion within 2 years) that require implant removal.The decision to do so
should only be made after a meticulous risk to benet assessment by a medical specialist.
The following complications can occur due to the presence of the implant in the body:
1. Corrosion, with local tissue inammation or pain
2. Implant migration, possibly leading to injuries
3. Risk of additional injuries, caused by post-surgical trauma
4. Distortion, loosening or breakage
5. Pain, symptoms or unusual sensitivity due to the presence of the implant
6. Risk of infection or inammation
7. Bone loss due to stress shielding
8. Potential, unknown or unexpected long-term eects
A prolonged healing phase, unsuccessful bony fusion or subsequent bone resorption or trauma can place undue stress on the implant,
which, in turn, could lead to implant failure.
Implant failure is possible even after successful fusion.
The implant removal must be followed up accordingly.
Explanted implants must not be reused.
The patient should be informed about the necessary behavior after the implantation procedure, including measures to be taken in case of
an event involving the implant. An implant card should be given to the patient.
7 Recommended application
Further description of the tezo application is included in the surgical technique, prepared as part of the overall documentation of the system.
It is also available at www.ifu.ulrichmedical.com.
8 Material Information
The tezo implants are manufactured from a titanium alloy according to ISO5832-3; ASTM F136.The devices are biocompatible, corrosion-re-
sistant and non-toxic in the intended use as per ENISO10993-1.
9 MRI Information MR
ulrich medical tezo implants are classied as "MR conditional" according to ASTM standard F2503.
The "MR Conditional" components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a tezo
implant can undergo an MRI examination under the following conditions:
eld strengths of 1.5T and 3.0 T
highest eld gradient of 30T/m (3000G/cm) or less
maximum specic absorption rate (SAR) of 2W/kg for normal operating mode for a scan time of 30minutes or 4W/kg for the rst level
controlled mode for a scan time of 15minutes
Note: In the experimental test, heating of a maximum of 6.0°C was measured at:
1.5 T and 3.0T
a 15-minute scan time
SAR 4 W/kg
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These scan conditions allow low-risk examination of patients.To minimize heating, the scan time should be as short as possible and the SAR
should be kept as low as possible.
Artifacts: MR imaging in the area of the implants can be impaired by artifacts. In the test, artifacts up to 22 mm were detected radially
around the implant.
The scans were performed with the following parameters:
FFE sequence:TR 100 ms,TE 15 ms, ip angle 30°
SE sequence:TR 500 ms,TE 20 ms, ip angle 70°
The SE sequence showed reduced artifacts (≤ 10 mm).
The attending physician should conduct a careful risk/benet assessment.
10 Packaging and storage
The product is delivered sterile. Sterility remains guaranteed provided the packaging is not opened or damaged and the expiry date has not
been exceeded. The product must be stored dry until it is used.
Corrosion may occur when instruments are stored under unfavorable conditions. In order to avoid this, they should be stored in a dry, dust-free
area. Signicant temperature uctuations are to be avoided, so that no moisture (condensation) accumulates on the instruments.
When directly exposed to metal, chemical substances may destroy this metal or release corrosive fumes. Therefore, instruments must not be
stored together with chemical substances.
The system-specic trays are to be used to store the instruments.
11 Identication and traceability
Implants are labeled with the catalogue number and batch code on the packaging label and, if technically feasible, these are marked on the
implant itself.
To ensure traceability, these data must be correspondingly documented in the hospital. For sterile-packed implants, corresponding adhesive
labels are included for documentation.
12 Disposal of used products
Follow country-specic regulations regarding disposal of hospital waste when disposing of used medical devices.
13 Cleaning, disinfection and sterilization
Reusability of tezo implants:
The implants are supplied sterile and may not be processed or sterilized again. Processing can lead to material damage that can impair the
function of the implants.
For cleaning, disinfection and sterilization of non-sterile instruments the "Processing manual implants and instruments" UH1100 that was
provided in the overall documentation of the system must be used. For individual instruments which are correspondingly marked in the surgi-
cal technique, the "Assembly and disassembly instructions with special cleaning instructions" that was provided in the overall documentation
of the system have to be considered.
These are also available at: www.ifu.ulrichmedical.com.
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14 Labeling and symbols
Catalogue number Batch code Quantity
Manufacturer Date of manufacture Use-by date
Do not use if package is
damaged Do not re-use Sterilized using irradiation
Caution: U.S. federal law restricts this device to sale by or on the order of a
physician Caution
Consult assembly and disassembly instructions with special cleaning
instructionsConsult instructions for use
CE mark with identication number of the notied body Non-sterile
MR MR Conditional – A product which does not demonstrate any deliberate hazards in the specic MRI environment
NON
STERILE
2019-07-02

WS 3495-eIFU
R6.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
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SYSTEM: tezo™ titanium cage family
COUNTRY: USA The only version applicable to users in Canada is the version intended especially for
Canada.
!Rx only BEFORE CLINICAL USE, TAKE NOTE OF THESE INSTRUCTIONS FOR USE AND THE SYSTEM-
RELATED SURGICAL TECHNIQUE!
Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
MANUFACTURER: DISTRIBUTED IN THE USA BY:
ulrich GmbH & Co. KG ulrich medical USA Inc.
Buchbrunnenweg 12 l 89081 Ulm l Germany 18221 Edison Avenue l Chestereld MO 63005 l USA
DESCRIPTION
The tezo™ Titanium Cage Family – consisting of tezo-P, tezo-T and tezo-A – is used for the surgical stabilization of the lumbosacral spine to
provide a suitable environment for fusion to occur. The system components include intervertebral devices available in a variety of height,
length, width and anteroposterior angulation combinations to accommodate diering patient anatomy.
Precaution: The implantation of tezo™ should be performed only by experienced spinal surgeons with specic training in the use of this
spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient. The surgeon treating the
patient bears the responsibility for the correct choice of patients, the required training and the experience with choosing and administering
implants. A copy of the surgical technique manual for the implantation of tezo™ can be obtained free of charge by contacting ulrich medical
USA at the address or phone number given at the end of this document or send an email to [e-mail].
MATERIAL INFORMATION
The tezo™ implants are manufactured from titanium alloy material (Ti-6Al-4V ELI) conforming to ASTM F136. The materials are biocompatible,
corrosion-resistant, non-toxic under biological conditions.
MR MR conditional
MRI information
ulrich medical tezo implants are classied as„MR conditional“ according to ASTM standard F2503.
The„MR conditional“componentsweretestedaccordingtothe ASTM standards: F2052; F2182; F2213 and F2119. A patientwitha tezo implant
can undergo an MRI examination under the following conditions:
Field strengths of 1.5T and 3.0 T
highest eld gradient of 30T/m (3000 G/cm) or less
maximum specic absorption rate (SAR) of 2 W/kg for normal operating mode for a scan time of 30 minutes or 4 W/kg for the rst level
controlled mode for a scan time of 15 minutes
Note: In the experimental test, heating of a maximum of 6.0°C was measured at:
1.5 T and 3.0T
a 15-minute scan time
SAR 4 W/kg
Under these scan conditions, the risks to the patient during an examination are low. To minimize heating, the scan time should be as brief as
possible and the SAR should be kept as low as possible.
Artefacts: MR imaging in the area of the implants can be impaired by artefacts. In the experimental test, there were artefacts up to 22 mm
radially around the implant.
The scans were performed with the following parameters:
FFE sequence:TR 100 ms,TE 15 ms, ip angle 30°
SE sequence:TR 500 ms,TE 20 ms, ip angle 70°
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The SE sequence demonstrates reduced artefacts (≤ 10 mm).
The attending physician should conduct a careful risk/benet assessment.
INDICATIONS/INTENDED USE
tezo™ is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of
non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc di-
sease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is dened as back pain of discogenic origin with degeneration of the disc
conrmedbyhistory andradiographicstudies.The device isintendedfor use with supplementalxationand with autografttofacilitatefusion.
CONTRAINDICATIONS
Patients with fever or leukocytosis
Patients with spine associated infections (e.g. spondylodiscitis)
Patients with proven material allergy or tendency to react to foreign bodies
Patients with obesity
Patients without adequate compliance who are not able due to their mental and/or neurological state or capable of adhering to the af-
tercare instructions
Patients with a poor general medical or psychological condition which could be further exacerbated by the intervention; in these patients
the attending surgeon/physician must carefully weigh the risks and benets
Patients with inadequate bone quality or quantity, e.g. severe osteoporosis, osteopenia, osteomyelitis
Patients who are pregnant
Patients with a prior fusion at the level to be treated.
Patients with any condition not described in the Indications for Use
!WARNINGS AND PRECAUTIONS
This product may only be used by an experienced surgeon/physician of spinal surgery.
The attending surgeon is responsible for the correct selection of patients, the training required and experience in the selection and place-
ment of the implants.
The patient must be given detailed information on the risks involved from the intervention and the use of the implant.
The surgeon/physician should discuss with the patient in detail the expected surgical result from the use of this product, particularly with
regard to possible physical limitations of the product. The postoperative level of activity will inuence the service life of the implant and the
durability of the implant in the bone.The patient must therefore be instructed about restrictions and risks in daily activities and any special
rules of behavior that may be necessary. Compliance with the surgeon/physician’s instructions is required. Special attention should be paid
to a postoperative conference and the necessity of regular medical follow-up examinations.
The correct selection and placement of the implant must be ensured and reviewed using appropriate pre-, intra- and postoperative diag-
nostic methods. Use of a C-arm is strongly recommended.
Errors in the choice of implant may lead to premature clinical implant failure. The number of segments has to be selected accurately. The
product should be used in the correct anatomic position, taking into consideration current standards for interbody fusion. The human
bone limits the size and resistance of the implant due to its shape and composition. Over the long term, the implant cannot withstand the
physiological, biomechanical forces without successful fusion of the bone. An implant which was initially implanted rmly may loosen over
time or its function become impaired.
The product must be handled and stored with care. Damage or scratches on the implant can considerably impair the rmness of the product
and its resistance to fatigue.
After the product has been used once, it cannot be used again under any circumstance. Even if the product appears to be undamaged,
previous strains can lead to irregularities which can shorten the lifespan of the product. Only new and undamaged implants must be used.
Used or damaged implants must be disposed of.
Thepatientshouldbe instructed toinformtheir surgeon/physicianimmediatelyregardinganyunusualchanges in the areaofthe operation.
The patient should be monitored in case any changes appear in the region of instrumentation. The surgeon/physician must then evaluate
whether clinical failure of the implant is occurred and discuss with the patient any necessary measures which must be taken to promote
further healing.
A delayed healing phase, lack of bone consolidation or subsequent bone resorption or trauma can lead to excessive stress on the implant
and loosening, deformation, cracking or breakage of the implant.
Patientswith previous spinal surgeryatthelevel(s)tobe treatedmayhavedierentclinicaloutcomescomparedtothosewithout a previous
surgery.
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Mixing of dissimilar metals can accelerate the corrosion process. Stainless steel and titanium implants must NOT be used together in buil-
ding a construct.
Components of this system should not be used with components of any other system or manufacturer.
POSSIBLE COMPLICATIONS
In many cases, possible complications are caused by use rather than the implant:
General risks and complications from the operation
Wound healing impairment
Infection
Cardiovascular complications e.g., cardiac arrest, pulmonary heart disease, pulmonary embolism, anemia, thrombosis, embolism, coagu-
lation disorder
Gastrointestinal complications such as: gastritis, stress ulcers, ileus, ulcers
Neurological complications e.g., spinal cord or nerve-root lesions with temporary or permanent sensory and/or motor impairments
Risk in anesthesia, risk in blood transfusions, positioning risks
Intraoperative injury to blood vessels, massive bleeding (hemorrhage)
Insucient correction and/or absence of bone fusion and necessity for renewal of stabilization
Implant removal or renewal of stabilization due to implant loosening, dislocation, sintering and/or implant failure
Local or systemic reactions due to incompatibility of the materials
Insucient subjective improvement of the complaint
USE OF GENUINE PRODUCTS
Implants and instruments are developed and manufactured for common use. Unforeseeable risks and/or contamination of the materials may
result from using the products of other manufacturers with those from ulrich medical®, or implants and instruments may not t together so
that the patient, user or third party may be put at risk. The implants may only be combined with the implants for which they are intended.
Only genuine instruments from the implant system, which are exclusively designed for the purpose, may be used for handling the implants.
Please refer to the special handling instructions on the packaging leaet of the implant and instrument concerned. Only genuine implants
must be used.
CLEANING, DISINFECTION AND STERILIZATION
Implant
The implants are delivered sterile and do not have to be sterilized again. Examine the packaging carefully before use to check whether the
packaging shows any signs of damage that could aect the sterility of the product. Under no circumstances may implants which have already
been in contact with a patient or have become contaminated be used again; these must be discarded.
Instrument processing instructions
ulrich GmbH & Co. KG ulrich medical USA
Buchbrunnenweg 12 18221 Edison Avenue
89081 Ulm l Germany Chestereld, MO 63005 | USA
Phone [phone] Phone: [phone], Fax: [phone]
Processing
Basic principles
Allinstruments,including the sterilizationlayersand trays,must be thoroughlycleaned,disinfected and sterilizedbeforeeach use; this applies
especially to the rst-time use after delivery because all instruments are shipped in non-sterile condition (clean and disinfect after removing
the transport packaging and sterilize after wrapping). Eective cleaning and disinfection is an indispensible prerequisite for eective steri-
lization. When using instruments, please make sure to keep dirty instruments separate and to not place them back into the instrument tray
in order to prevent serious contamination of the equipped instrument tray. Clean/disinfect the dirty instruments, sort them and place them
back in the instrument tray, then sterilize the entire equipped instrument tray.Within the scope of your responsibility for instrument sterility,
please ensure that only cleaning/disinfection and sterilization processes which have been appropriately validated in a device-specic and
product-specic manner are used, that the employed devices (disinfecting machine, sterilizer) undergo regular maintenance and inspections
and that the validated parameters are complied with during each cycle. In addition, please follow all applicable laws in your country as well as
the hygiene regulations of the medical practice or hospital in question.This applies especially to the various requirements regarding eective
prion inactivation.
Instruments intended for one-time use may not be reprocessed.
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Never use wire brushes or steel wool to clean any instruments, instrument storage trays or sterilization containers.
Cleaning and disinfection
Basic principles
Use a mechanical procedure (disinfecting machine) to clean and disinfect the instruments, when possible. Because a manual procedure is
considerably less eective and reproducible (even when using an ultrasonic bath), it should only be used when a mechanical procedure is
unavailable. Instruments must be taken out of the trays for cleaning and disinfecting!
Pretreatment
Pretreatment must be done for both mechanical and manual processes. Major impurities must be removed from the instruments directly after
use (within max. 2 hours). Use running water or a disinfectant for this; the disinfectant should be aldehyde-free (otherwise xation of blood
impurities could occur), be demonstrably eective (e.g. FDA clearance), be suitable for instrument disinfection and be compatible with the
instruments (see the„Material stability“ section). To remove impurities manually, use only a soft brush or a clean, soft cloth which you use
exclusively for this purpose; never use a metal brush or steel wool.
Move moveable parts, such as push-buttons/release buttons or hinges, during the preliminary cleaning.
If applicable: Rinse all the lumina of the instruments ve times using a disposable syringe (minimum volume: 50 ml).
The disinfectant used during pretreatment is only intended for personal protection and does not replace the subsequent disinfection step
after successful cleaning.
Mechanical cleaning/disinfection of instruments
When selecting a disinfecting machine, please ensure that:
The disinfecting machine features proven evidence of ecacy, (e.g. FDA clearance);
If possible, a tested thermal disinfection program should be used (A0value > 3000, or, for older devices, at least 10 minutes at 93 °C [199 °F])
(chemical disinfection runs the risk of leaving disinfectant residues on the instruments);
The used program is suitable for the instruments and contains sucient rinsing cycles;
The water used (e.g., puried water/highly puried water) for rinsing is sterile or nearly sterile (no more than 10 microbes/ml) and low in
endotoxins (no more than 0.25 endotoxin units/ml).
Filtered air is used for drying; and
The disinfecting machine undergoes regular maintenance and inspections.When selecting a cleaning agent system, please ensure that:
It is suitable for cleaning the instruments;
If no thermal disinfection is used – a suitable disinfectant with proven ecacy (e.g. FDA clearance) is additionally used and that it is compa-
tible with the employed cleaning agent;
The manufacturer‘s concentrations and application times for the cleaning agent and/or disinfectant are strictly complied with.
Process for mechanical cleaning/disinfection of instruments
1. Disassemble the instruments according to the manufacturer‘s instructions.
2. Place the disassembled instruments into the disinfecting machine. Place the instruments which, according to the manufacturer‘s inst-
ructions, do not need to be disassembled entirely into the disinfecting machine. Make sure that the instruments do not touch each other.
3. Close all lumina of the instruments (using a suitable ush adapter) on the disinfectant machine‘s ush connection.
4. Open instruments with hinges in order to minimize contact of the components amongst themselves. Fixate the hinges with spring mecha-
nism with the corresponding tools, if necessary.
5. Start the program.
6. Remove the instruments from the disinfecting machine after the program has nished. Ensure that the instruments are dry after cleaning/
disinfection. If necessary, subject the instruments to additional drying in a clean location.
7. Check and package the instruments as soon as possible after removal (see the„Inspection,“„Maintenance“ and„Packaging“ sections).
Manual cleaning/disinfection of instruments
Combined cleaning agents/disinfectants should only be used in the event of extremely little initial impurity (no visible impurities) of the
instruments.
Process for manual cleaning of instruments
1. Disassemble the instruments according to the manufacturer’s instructions.
2. Place the disassembled instruments into the cleaning bath for the specied application time so that the instruments are suciently im-
mersed (if necessary, use ultrasound or carefully clean with a soft brush). Place the instruments which, according to the manufacturer’s
instructions, do not need to be disassembled entirely into the cleaning bath for the specied application time so that the instruments are
suciently immersed (if necessary, use ultrasound or carefully clean with a soft brush).While doing so, ensure that the instruments do not
touch each other.
3. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable
syringe (minimum volume: 50 ml), a suitable ush adapter and a sterilization agent and disinfectant for ultrasonic cleaning.
4. Clean the instruments in the ultrasonic bath (35 to 40kHz) for 5 minutes.
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5. Remove the instruments from the cleaning bath and rinse them thoroughly (at least 1 minute) under running water.
6. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable
syringe (minimum volume: 50 ml).
7. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run o completely. If necessary, subject the instruments
to additional drying in a clean location.
8. Inspect the instruments (see the„Instrument inspection“ and„Maintenance“ sections).
Instrument disinfection during manual cleaning
1. Place the disassembled and non-disassembled (see manufacturer‘s instructions), cleaned and inspected instruments into the disinfecting
bath for the specied application time so that the instruments are suciently immersed. Make sure that the instruments do not touch each
other.
2. If applicable: Rinse all the lumina of the instruments ve times at the beginning and/or end of the application time using a disposable
syringe (minimum volume: 50 ml).
3. Remove the instruments from the disinfecting bath and rinse them thoroughly (at least 1 minute) under running water.
4. If applicable: Rinse all the lumina of the instruments using a disposable syringe (minimum volume: 50 ml).
5. Dry the instruments in suitable containers after cleaning. Ensure that liquids can run o completely. If necessary, subject the instruments
to additional drying in a clean location.
6. Package the instruments as soon as possible after removal (see the„Packaging“ section).
Instrument inspection
Inspect all the instruments, including thesterilization layersand trays, after cleaning or cleaning/disinfectingforcorrosion,damaged surfaces,
chips and impurities and separate out all damaged instruments. Instruments that are still dirty must be cleaned and disinfected again.
Maintenance
Reassemble all disassembled instruments. Subject all instruments to a functional test. Apply instrument oil to all moveable parts such as
push-buttons, sliding sleeves, closures on tongs, latches, threaded spindles, etc. for maintenance purposes. Instrument oils should not be
used other than for the above purpose whenever possible. Only instrument oils (white oil) should be used which – taking into consideration
the maximum applied sterilization temperature – are approved for steam sterilization and feature proven biocompatibility. As a rule, no oil
may be applied to silicone parts.
Packaging
Sort the cleaned and disinfected instruments and place them into the proper instrument tray and package them in suitable sterilization
packaging (i.e., FDA cleared sterilization wrap).
Do not use if package is damaged
Steam sterilization
The implants and instruments have been found to be thoroughly suitable for eective steam sterilization by an independent accredited labo-
ratory using the following parameters.
Validation was performed during the half-cycle. Only the following sterilization procedure is to be used. Other sterilization procedures are
not permitted.
Cycle: Gravity
Temperature: 270°F (132°C)
Exposure time: 15 min.
Drying time: 60 min.
Testing has shown these parameters to result in a sterility assurance level (SAL) of 10-6.
Do not use hot-air sterilization or radiation sterilization procedures. Do not stack implant
and/or instrument trays. Flash sterilization is not permissible under any circumstances! All instruments, instrument trays and sterilization
containers must not be exposed to temperatures of 141°C (286 °F) or more!
Storage
After sterilization, the instruments must be stored in the sterilization packaging, dry and free of dust.
Material stability
When choosing the cleaning agent and disinfectant, make sure that they do not contain the following components:
Anticorrosives/corrosion inhibitors (triethanolamines are particularly problematic)
Strong organic, mineral and oxidizing acids
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Relatively strong bases (pH must not exceed 12 for instruments made of metal and 10.5 for aluminium/ferrozell ones; neutral or weakly
alkaline cleaning agents are recommended)
Solvents (such as alcohols and acetone) and gasoline
Oxidizing agents
Ammonia
Chlorine and iodine
Product Complaints:
Any dissatisfaction with the product quality, labelling or performance should be reported to ulrich medical USA immediately by the customer
or health care provider. Furthermore, if any of the implants“malfunction,”(i.e., do not meet any of their performance specications or other-
wise do not perform as intended) and may have caused or contributed to the death or serious injury of the patient ulrich medical USA should
be notied immediately by telephone, fax, or written correspondence.When ling a complaint, the name, part number and lot number of the
part should be provided along with the name and address of the person ling the complaint.
For additional information and product complaints, please contact:
ulrich medical USA, Inc.
18221 Edison Avenue
Chestereld, MO 63005
Phone: [phone]
Fax: [phone]
2019-07-02

WS 3495-eIFU
R6.1/2019-03
ulrich GmbH & Co. KG l Buchbrunnenweg12 l 89081 Ulm l Germany
Phone: [phone] l Fax: [phone]
[email protected] l www.ulrichmedical.com
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SYSTEM: tezo™ titanium cage family
COUNTRY: Canada
The only version applicable to users in the U.S. is the version intended especially for the United States.
Read all instructions carefully. Failure to follow instructions, warnings and precautionary measures
may have severe consequences or result in patient injury.
Take into careful consideration all product materials before clinical use.
The required product materials prepared as overall documentation of the system are: system related
instructions for use, surgical technique and, if applicable, supplements, assembly and disassembly
instructions, as well as "Processing manual implants and instruments" UH1100.
1 Product description
tezo are implants for lumbosacral interbody fusion. The ALIF technique (Anterior Lumbar Interbody Fusion), the PLIF technique (Posterior
Lumbar Interbody Fusion) or the TLIF technique (Transforaminal Lumbar Interbody Fusion) can be used. The cages can be used for bridging and
stabilizing the intervertebral space with the purpose of supporting bony fusion. The reconstruction of the spinal prole is achieved through
the size, height, and angulation of the cages, among others. The cages are to be lled with bone/bone graft material and provide optimal
space for bony fusion.
2 Indications/Intended use
tezo is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of
non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc di-
sease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is dened as back pain of discogenic origin with degeneration of the disc
conrmedbyhistory andradiographicstudies.The device isintendedfor use with supplementalxationand with autografttofacilitatefusion.
3 Contraindications
Patients with fever or leukocytosis
Patients with spine associated infections (e.g. spondylodiscitis)
Patients with proven material allergy or tendency to react to foreign bodies
Patients with obesity
Patients without adequate compliance who are not able due to their mental and/or neurological state or capable of adhering to the
aftercare instructions
Patients with a poor general medical or psychological condition which could be further exacerbated by the intervention; in these patients
the attending surgeon/physician must carefully weigh the risks and benets
Patients with inadequate bone quality or quantity, e.g. severe osteoporosis, osteopenia, osteomyelitis
Patients who are pregnant
Patients with a prior fusion at the level to be treated.
Patients with any condition not described in the Indications for Use
4 Possible side eects
Possible complications associated with the implant are:
Implant loosening, dislocation and/or implant failure
Local or systemic reactions due to material intolerance
Failure of bony fusion
Adjacent segment degeneration
These possible complications may lead to further surgical interventions (implant removal or stabilization renewal). Other complications which
may be caused by the surgical procedure itself and independent of the implant are:
General surgical risks and complications
Anesthesia and blood transfusion risks as well as positioning damage
Lung complications
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Infection
Wound healing disorders
Cardiovascular complications, such as blood loss, thrombosis, embolism, coagulopathy
Gastrointestinal complications, such as gastritis, ileus, ulcer
Neurological complications, such as spinal cord or neural root lesions with temporary or permanent sensory and/or motor disturbances
(bladder and rectal disorders, sexual dysfunction)
Intraoperative injury to blood vessels, massive hemorrhage, stroke, cerebral hemorrhage with potential life-threatening consequences
Injury to organs adjacent to the spine, such as cervical, thoracic and abdominal organs, depending on the region operated on
5 Warnings and precautions
5.1 General
The user has to ensure that the most current versions of the complete product materials provided as overall documentation of the system
are on hand and considered. These are also available at: www.ifu.ulrichmedical.com. A printed copy may be delivered within 7 days,
upon request.
This product must be used only by an experienced spine surgeon, under sterile conditions and in an operating room where C-arm is
available.
The treating physician is responsible for making the proper selection of patients, and for acquiring the training with the system and
experience required for implant selection and placement.The treating physician is also responsible for determining whether to leave the
implant following surgery or to remove it.
The product must be carefully handled and stored. Implants with any kind of damage or scratches must not be used, as product stability
and resistance to fatigue may be aected.
Implants of the corresponding ulrich medical systems must be used exclusively with the system-specic instruments intended for this
purpose, unless otherwise indicated.
Connecting ulrich medical implants to implant components of other manufacturers is not permitted. A combination with other implants
from ulrich medical is not permitted.
Given the presence of passive layers, corrosion of metal implants is very minimal. Nevertheless, there may be accelerated material fatigue
and the possibility of a break, as well as increased release of metal components in the body. Corrosion is promoted by the components
made of dierent metals coming into contact and by damage to the implant’s surface. Direct contact with metal implants from other
manufacturers is not allowed.
5.2 Preoperative
Implantation should only be considered when all other treatment options have been carefully weighed and ruled out as a possible better
option. A successful implant itself will also be inferior to the healthy moving element(s) of the spine. On the other hand, an implant may
be benecial for the patient by replacing one or more severely deformed or degenerated moving elements since this eliminates pain and
a good load bearing capacity can be achieved.
The risks of the procedure and the use of the implant, including any revisions which may be necessary, should be explained to the patient
in detail.
The treating physician should conduct with the patient a detailed discussion of the surgical results that may be anticipated, particularly
with regard to potential physical limitations of the implant. The degree of postoperative activity aects the life time of the implant and
the stability of the implant in the bone. Thus, the patient must be informed of the limitations and risks inherent in daily activities and
made aware of special guidelines for movement. Smoking can inhibit fusion and may predispose to an increased rate of pseudoarthrosis.
Patients should be informed about the possible negative eects of smoking on the success of a fusion procedure. The treating physician
must assess whether the patient can understand and follow such instructions. Special attention should be given to postoperative
discussion and the need for regular medical monitoring.
Ensure that suitable pre-, intra- and postoperative diagnostic procedures are performed to evaluate and ensure proper implant selection
and placement.
Errors in implant selection could result in premature clinical implant failure. The number of segments to be treated must be accurately
determined.The shape and composition of human bones limits the size and durability of the implant.
5.3 Intraoperative
The implant is delivered sterile and must not be resterilized.
Do not use the implant if the packaging is damaged or was opened outside the sterile area.
Do not use the implant if the expiry date has passed.
Use aseptic techniques in order to avoid contamination when taking the implant out of the sterile packaging and when using the implant.
tezo-P implants are intended exclusively for use in pairs in the intervertebral space.
After the implant has been in contact with a patient, has been soiled or used, it must not be reused and must be discarded. Even if the
exterior of the implant appears unchanged, prior stress may have caused damage that can lead to implant failure.
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To achieve fusion, the implant should always be inserted into the intervertebral space with autograft.
5.4 Postoperative
The patient should be instructed to inform his or her treating physician immediately regarding any unusual changes in the area where
the surgery was performed.
The patient should be monitored for any changes to the implant area. The treating physician should assess the potential for clinical
implant failure and discuss with the patient the necessary measures to promote further healing.
The inserted implant serves to reconstruct substance defects of the surgical site over a maximum two-year healing process. After the
surgical site is fused, the implant is rmly anchored in the bone. The implant is therefore not intended to be removed unless there are
complications, implant failure, or a delayed healing phase (no fusion within 2 years) that require implant removal.The decision to do so
should only be made after a meticulous risk to benet assessment by a medical specialist.
The following complications can occur due to the presence of the implant in the body:
1. Corrosion, with local tissue inammation or pain
2. Implant migration, possibly leading to injuries
3. Risk of additional injuries, caused by post-surgical trauma
4. Distortion, loosening or breakage
5. Pain, symptoms or unusual sensitivity due to the presence of the implant
6. Risk of infection or inammation
7. Bone loss due to stress shielding
8. Potential, unknown or unexpected long-term eects
A prolonged healing phase, unsuccessful bony fusion or subsequent bone resorption or trauma can place undue stress on the implant,
which, in turn, could lead to implant failure.
Implant failure is possible even after successful fusion.
The implant removal must be followed up accordingly.
Explanted implants must not be reused.
The patient should be informed about the necessary behavior after the implantation procedure, including measures to be taken in case of
an event involving the implant. An implant card should be given to the patient.
6 Recommended application
Further description of the tezo application is included in the surgical technique, prepared as part of the overall documentation of the system.
It is also available at www.ifu.ulrichmedical.com.
7 Material Information
The tezo implants are manufactured from a titanium alloy according to ISO5832-3; ASTM F136. The devices are biocompatible, corrosion-
resistant and non-toxic in the intended use as per ENISO10993-1.
8 MRI Information MR
ulrich medical tezo implants are classied as "MR conditional" according to ASTM standard F2503.
The "MR Conditional" components were tested according to the ASTM standards: F2052; F2182; F2213 and F2119. A patient with a tezo
implant can undergo an MRI examination under the following conditions:
eld strengths of 1.5T and 3.0 T
highest eld gradient of 30T/m (3000G/cm) or less
maximum specic absorption rate (SAR) of 2W/kg for normal operating mode for a scan time of 30minutes or 4W/kg for the rst level
controlled mode for a scan time of 15minutes
Note: In the experimental test, heating of a maximum of 6.0°C was measured at:
1.5 T and 3.0T
a 15-minute scan time
SAR 4 W/kg
These scan conditions allow low-risk examination of patients.To minimize heating, the scan time should be as short as possible and the SAR
should be kept as low as possible.
Artifacts: MR imaging in the area of the implants can be impaired by artifacts. In the test, artifacts up to 22 mm were detected radially
around the implant.
The scans were performed with the following parameters:
FFE sequence:TR 100 ms,TE 15 ms, ip angle 30°
SE sequence:TR 500 ms,TE 20 ms, ip angle 70°
The SE sequence showed reduced artifacts (≤ 10 mm).
2019-07-02