B. Braun Aesculap S4 Manual

Aesculap®
Aesculap Spine
en Instructions for use/Technical description
S4® Spinal System - Lumbar/Deformity
USA Note for U.S. users
This Instructions for Use is NOT intended for United States users. Please discard. The Instructions for Use
for United States users can be obtained by visiting our website at www.aesculapImplantsystems.com and
clicking the "Products" menu. If you wish to obtain a paper copy of the Instructions for Use, you may
request one by contacting your local Aesculap representative or Aesculap's customer service at 1-866-
229-3002. A paper copy will be provided to you upon request at no additional cost.
de Gebrauchsanweisung/Technische Beschreibung
S4® Spinal System - Lumbar/Deformity
fr Mode d’emploi/Description technique
S4® Spinal System - Lumbar/Deformity
es Instrucciones de manejo/Descripción técnica
S4® Spinal System - Lumbar/Deformity
it Istruzioni per l’uso/Descrizione tecnica
S4® Spinal System - Lumbar/Deformity
pt Instruções de utilização/Descrição técnica
S4® Spinal System - Lumbar/Deformity
nl Gebruiksaanwijzing/Technische beschrijving
S4® Spinal System - Lumbar/Deformity
sv Bruksanvisning/Teknisk beskrivning
S4® Spinal System – Lumbar/Deformity
ru Инструкция по примению/Техническое описание
S4® Spinal System – Lumbar/Deformity
cs Návod k použití/Technický popis
S4® Spinal System - Lumbar/Deformity
pl Instrukcja użytkowania/Opis techniczny
S4® Spinal System – Lumbar/Deformity
sk Návod na použitie/Technický opis
S4® Spinal System - Lumbar/Deformity
tr Kullanım Kılavuzu/Teknik açiklama
S4® Spinal Sistem - Lumbar/Deformity
zh 使用说明 /技术说明
腰椎后路固定系统
Aesculap AG | Am Aesculap-Platz | 78532 Tuttlingen | Germany
Phone [phone] | Fax [phone] | www.aesculap.com
Aesculap®– a B. Braun brand
TA011187 2019-09 V6 Change No. 60104
0482

en
Aesculap®
S4® Spinal System - Lumbar/Deformity
Legend
Fig. 1 S4monoaxial screws
Fig. 2 S4Element monoaxial screws
Fig. 3 S4polyaxial screws
Fig. 4 S4Element polyaxial screws
Intended use
The S4Spinal System-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar
and thoracic spine. They comprise:
■Mono/polyaxial screws
■Rods
■Hook
■Cross connector
■Rod connectors – parallel, axial and lateral offset
■appropriate fixation elements
Special instruments must be used for implanting these components, as well as for the distraction, compression and
reduction of the lumbar and thoracic spine.
Materials
The materials used in the implant are listed on the packaging:
■ISOTAN®Ftitanium forged alloy Ti6Al4V acc. to ASTM F136/ISO 5832-3
■ISOTAN®Ppure titanium acc. to ASTM F67/ISO 5832-2
The titanium implants are coated with a colored oxide. Slight changes in coloration may occur, but do not affect the
implant quality.
ISOTAN® is a registered trademark of Aesculap AG, 78532 Tuttlingen / Germany.
Indications
Surgically installed implants serve to support normal healing processes. They are not intended for use either as
replacements for natural body parts or to bear loads over the long term in the event the healing process is incomplete
or slow.
Use for acute disorders of the spine that cannot be treated by other therapies:
■Fractures
■Pseudarthrosis or delayed healing
■Dislocation
■Degenerative instability
■Post-discectomy syndrome
■Spondylolisthesis
■Kyphosis
■Scoliosis
■Stenosis
■Post-trauma instability
■Tumors
■Osteoporosis (with the simultaneous use of bone cement and fenestrated screws)
Absolute contraindications
Do not use in the presence of:
■Severe damage to the bone structures of the spine that could prevent the stable implantation of the implant
components; for example, osteopenia, severe osteoporosis, Paget’s disease, bone tumors etc.
■Metabolic or degenerative metabolic bone diseases that could compromise the stable anchoring of the implant
system
■Suspected allergy or sensitivity to the implant materials
■Acute or chronic vertebral infections of a local or systemic nature
■Poor patient compliance or limited ability to follow medical instructions, particularly in the post-op phase,
including with regard to the restrictions on range of movement in terms of physical exercise and occupational
activity
■Cases not listed under indications
Relative contraindications
In the following circumstances, use of the implant system could represent an increased clinical risk and therefore
requires precise, individual assessment by the surgeon:
■Medical or surgical conditions that could negatively impact the success of the implantation, including wound
healing disorders
■Conditions that could subject the spine and implants to excessive pressure,
■for example, pregnancy, obesity, neuromuscular diseases or disorders
■Generally poor condition of the patient; for example, drug or alcohol addiction
Side effects and interactions
The general risks of surgery are assumed known and are therefore not described in these instructions for use. Poten-
tial risks and clinical consequences associated with use of the implant system include, but are not limited to:
■Implant failure resulting from excessive load
– Warping or bending
– Loosening
–Breakage
■Poor stabilization, requiring subsequent revision surgery or surgery to remove the implant system
■Failed or delayed fusion
■Infection
■Fractured vertebral body or bodies
■Tissue reaction to implant materials
■Hematomas and wound healing disorders
■Injuries to
– Nerve roots
– Spinal cord
– Blood vessels
–Organs
■Changes of the normal spine lordosis
■Neurological disorders, including impairment of the gastrointestinal, urological and/or reproductive system
■Pain or indisposition
■Bursitis
■Decreased bone density due to load avoidance
■Bone atrophy/fracture above or below the spine section provided for
■Limited physical ability
■Persistence of symptoms that were to be treated by the implantation
■Paresis
■Subsequent surgery to remove the implant system
■Metal/foreign body allergy or hypersensitivity
■Dural tears
■Meningitis
Safety notes
■It is the operating surgeon's responsibility to ensure that the surgical procedure is performed properly.
■General risk factors associated with surgical procedures are not described in this documentation.
■The operating surgeon must have a thorough command of both the hands-on and conceptual aspects of the
established operating techniques.
■The operating surgeon must be fully conversant with bone anatomy, including the pathways of nerves, blood ves-
sels, muscles, and tendons.
■The operating surgeon is responsible for combining and implanting the implant components, with or without
bone cement.
■Aesculap is not responsible for any complications arising from erroneous indication, wrong choice of implant,
incorrect combination of implant components and operating technique, the limitations of the treatment method,
or inadequate asepsis.
■The instructions for use of the individual Aesculap implant components and instruments must be observed.
■The implant components were tested and approved in combination with Aesculap components. If other combi-
nations are used, the responsibility for such action lies with the operating surgeon.
■Do not, under any circumstances, combine implant components from different manufacturers.
■Do not, under any circumstances, use damaged or surgically excised components.
■Implants that have been used before must not be reused.
■Delayed healing can cause implant breakage due to metal fatigue.
■The attending physician shall make any decision with regard to the removal of implant components that have
been used,
■Damage to the load-bearing structures of the implant can lead to loosening of components, dislocation, migra-
tion, and other severe complications.
■To ensure the earliest possible detection of such causes of dysfunction, the implant must be checked periodically,
using appropriate techniques.
■The implant components applied, along with their article numbers, the name of the implant, as well as the batch
number and serial number (if available) must be documented in all patient records.
■Postoperatively, individual patient information, as well as mobility and muscle training, is of particular impor-
tance.
Sterility
■The implant components are supplied in an unsterile condition.
■The implant components are packaged individually.
►Store implant components in their original packaging and remove from their original protective wrapping only
immediately prior to processing.
►Use a suitable tray for cleaning/disinfection.
►Ensure that the implant components in their implant system storage devices do not come into contact with each
other or with instruments.
►Ensure that the implant components are not damaged in any way.
Prior to initial sterilization and subsequent resterilization, the implant components must be cleaned using the fol-
lowing validated reprocessing procedure:
Note
Adhere to national statutory regulations, national and international standards and directives, and local, clinical
hygiene instructions for sterile processing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant
national regulations concerning the reprocessing of products.
Note
Successful processing of this medical device can only be ensured if the processing method is first validated. The oper-
ator/sterile processing technician is responsible for this.
The recommended chemistry was used for validation.
Note
For up-to-date information about reprocessing and material compatibility, see also the Aesculap Extranet at
https://extranet.bbraun.com
The validated steam sterilization procedure was carried out in the Aesculap sterile container system.
Validated reprocessing procedure
Cleaning/Disinfection
Validated cleaning and disinfecting procedure
WARNING
Risk of screw breakage caused by pedicle screws used for spondylolisthesis!
►Support the stabilization measure with an intercorporal fusion (ALIF, PLIF or
TLIF).
WARNING
The implant has not been evaluated for safety and compatibility in the MR envi-
ronment. It has not been tested for heating, migration or image artifact in the MR
environment. Scanning a patient who has this implant may result in patient injury.
WARNING
Intraoperative contamination with blood, secretions, and other fluids may render
the affected component unsuitable for resterilization!
►Handle the implants with new gloves only.
►Keep the implant system storage devices covered or closed.
►Process implant system storage devices separately from instrument trays.
►Clean implants must not be processed together with contaminated implants.
►Process the implant components individually and separately if no implant sys-
tem storage devices are available, ensuring that the implant components are
not damaged in the process.
►Do not reuse surgically contaminated implants!
WARNING
Direct or indirect contamination may render implants unsuitable for resteriliza-
tion!
►Do not reprocess implants that have been directly or indirectly contaminated
with blood.
Validated procedure Specific requirements Reference
Manual cleaning with immersion
disinfection
■SW790T
■Do not clean with brushes or
other abrasives that would
damage the product surface.
■To prevent internal stresses and
weakening of the implants,
avoid scoring or scratching any
components.
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■Chapter Manual cleaning with
immersion disinfection

Manual cleaning/disinfection
Manual cleaning with immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infecting procedure.
Phase I
►Fully immerse the product in the cleaning/disinfectant for at least 15 min. Ensure that all accessible surfaces are
moistened.
►Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solution.
►Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►Rinse lumens at least 5 times at the beginning of the exposure time using an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible surfaces).
►Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
►Rinse lumens with an appropriate disposable syringe at least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfecting procedure.
Manual cleaning with ultrasound and immersion disinfection
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
RT: Room temperature
*Recommended: BBraun Stabimed
►Note the information on appropriate cleaning brushes and disposable syringes, see Validated cleaning and dis-
infecting procedure.
Phase I
►Clean the product in an ultrasonic cleaning bath (frequency 35 kHz) for at least 15 min. Ensure that all accessible
surfaces are immersed and acoustic shadows are avoided.
►Clean the product with a suitable cleaning brush in the solution until all discernible residues have been removed
from the surface.
►If applicable, brush through non-visible surfaces with an appropriate cleaning brush for at least 1 min.
►Mobilize non-rigid components, such as set screws, links, etc. during cleaning.
►Thoroughly rinse through these components with the cleaning disinfectant solution (at least five times), using a
disposable syringe.
Phase II
►Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►Drain any remaining water fully.
Phase III
►Fully immerse the product in the disinfectant solution.
►Mobilize non-rigid components, such as set screws, joints, etc. during rinsing.
►Rinse lumens at least five times at the beginning of the exposure time with an appropriate disposable syringe.
Ensure that all accessible surfaces are moistened.
Phase IV
►Rinse/flush the product thoroughly (all accessible surfaces) under running water.
►Mobilize non-rigid components, such as set screws, joints, etc. during final rinse.
►Rinse lumens with an appropriate disposable syringe at least five times.
►Drain any remaining water fully.
Phase V
►Dry the product in the drying phase with suitable equipment (e.g. cloth, compressed air), see Validated cleaning
and disinfecting procedure.
For implant components that are to be resterilized:
Mechanical cleaning/disinfecting
Note
The cleaning and disinfection device must be of tested and approved effectiveness (e.g. FDA approval or CE mark
according to DIN EN ISO 15883).
Note
The cleaning and disinfection device used for processing must be serviced and checked at regular intervals.
Mechanical alkaline cleaning and thermal disinfecting
Machine type: single-chamber cleaning/disinfection device without ultrasound
D–W: Drinking water
FD–W: Fully desalinated water (demineralized, low microbiological contamination: drinking water quality
at least)
*Recommended: BBraun Helimatic Cleaner alkaline
►Check visible surfaces for residues after mechanical cleaning/disinfecting.
Sterilization
►Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
►When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
■Selection of the implant components and their dimensions
■Positioning of the implant components in the bone
■Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
■All requisite implant components are ready to hand.
■Operating conditions are highly aseptic.
■All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
■The operating surgeon and operating room team are thoroughly conversant with the operating technique and
with the available range of implants and instruments; information materials on these subjects must be complete
and ready to hand.
■The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
■The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
■Special instruments ready for implanting the implant components and for the distraction, compression and
reduction of the lumbar and thoracic spine
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
■In the case of delayed or incomplete fusion, the implants can break and loosen due to high loads.
■The life-span of the implant depends on the patient’s body weight.
■The implant components must not be overloaded by extreme strains, hard physical labor or sports.
■Corrective surgery may be necessitated by implant loosening, fracture or loss of correction.
■Smokers present an increased risk of bone fusion failure.
■The patient must undergo medical check-ups of the implant components at regular intervals.
■The patient must be advised that being overweight places such excessive pressure on the implant that the pros-
pect of failure becomes likely.
Manual cleaning with ultrasound
and immersion disinfection
■Do not clean with brushes or
other abrasives that would
damage the product surface.
■To prevent internal stresses and
weakening of the implants,
avoid scoring or scratching any
components.
Chapter Manual cleaning/disinfec-
tion and sub-chapter:
■Chapter Manual cleaning with
ultrasound and immersion dis-
infection
Mechanical alkaline cleaning and
thermal disinfection
■SW790T
■Place the product in a tray that
is suitable for cleaning (avoid-
ing rinsing blind spots).
Chapter Mechanical cleaning/dis-
infecting and sub-chapter:
■Chapter Mechanical alkaline
cleaning and thermal disinfect-
ing
Phase Step T
[°C/°F]
t
[min]
Conc.
[%] Water quality Chemical
I Disinfecting clean-
ing RT (cold)
>15 2 D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
II Intermediate rinse RT
(cold)
1- D–W-
III Disinfection RT
(cold)
15 2 D–W Aldehyde-free, phenol-free, and
QUAT-free concentrate, pH ~ 9*
IV Final rinse RT
(cold)
1- FD-W-
V Drying RT - - - -
Phase Step T
[°C/°F]
t
[min]
Conc.
[%] Water quality Chemical
I Ultrasonic cleaning RT
(cold)
>15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
II Intermediate rinse RT
(cold)
1- D–W-
III Disinfection RT
(cold)
15 2 D–W Aldehyde-free, phenol-free,
and QUAT-free concentrate,
pH ~ 9*
IV Final rinse RT
(cold)
1- FD-W-
V Drying RT - - - -
Validated procedure Specific requirements Reference
Phase Step T
[°C/°F]
t
[min]
Water
quality Chemical/Note
I Prerinse <25/77 3 D–W -
II Cleaning 55/131 10 FD-W ■Concentrate, alkaline:
–pH=13
– <5 % anionic surfactant
■0.5 % working solution
– pH = 11*
III Intermediate rinse >10/50 1 FD-W -
IV Thermal disinfecting 90/194 5 FD-W -
V Drying - - - According to the program for cleaning
and disinfection device

■The patient must be advised that strenuous physical activity in the form of heavy lifting, excessive muscle strain,
exaggerated twisting, repeated bending and bending over or running should be avoided until the bones have
healed fully.
■The patient must be instructed to keep pressure off the implant post surgery in order to prevent the onset of
clinical problems associated with implant failure.
Implantation of the S4Spinal System implant requires the following steps:
►Select the appropriate S4Spinal System variant and and anchoring implants according to the individual indica-
tion, preoperative planning and bone situation found intraoperatively.
►Apply cannulated monoaxial screws when using FRI instruments.
►When selecting S4Spinal System screw types, make certain to select the correct diameter, length and canal ori-
entation.
►To avoid internal stress on, and weakening of, the implant: avoid scoring or scratching of the implant compo-
nents.
►Do not bend metal implants, except for the rods and the occipital plates of S4Spinal System.
►Make certain the insert is correctly positioned before placing the rod and after manipulating it.
►Adjust the curvature of the rod to the anatomical situation.
►Do not bend back, or bend excessively, the rods and cross connectors.
►Only use the bending instruments of the S4Spinal System instrument set for bending the rods and occipital
plates.
►To position the locking screw, always use the locking screw insertion instrument intended for this purpose.
►For tightening and loosening the locking screw, always use the screwdriver and countering instrument intended
for this purpose.
►Always tighten the locking screws with the torque wrench intended for this purpose.
►Always use the appropriate flank breaking forceps for breaking off the flanks (not applicable for S4element).
►If the screw head comes loose during revision of the larger polyaxial screws (∅7.5 mm or larger), remove the
remaining screw component with the SW 3.5 screwdriver.
►For tightening the locking screws of the cross connector, always use the torque wrench and countering instru-
ment intended for this purpose.
To implant the S4Spinal System rod connector, proceed as follows:
►Place the rod connector on the rod at the site calculated by the operator with the aid of the connector inser-
tion/fixing instrument intended for this purpose.
►Do not unscrew the locking screws from the rod connector.
►Do not exchange the locking screw with the other rod connector components.
►Do not use the rod connector if any locking screws are missing.
►Before tightening up the locking screws, ensure that the rod connector is positioned correctly.
►For tightening and loosening the locking screws, always use the screwdriver and countering instrument intended
for this purpose.
►Always tighten the locking screws with the torque 4 Nm wrench FW207R intended for this purpose.
►Only load the locking screws axially when tightening or loosening. Avoiding exerting lateral forces whilst tight-
ening or loosening the locking screws.
Further information on Aesculap implant systems is always available from B. Braun/Aesculap or the appropriate
B. Braun/Aesculap office.
Disposal
►Adhere to national regulations when disposing of or recycling the product, its components and its packaging!
TA011187 2019-09 V6 Change No. 60104
WARNING
Inadequate fixation due to incorrect screw selection!
►Apply cannulated monoaxial screws when using FRI instruments.
WARNING
Incorrect application can result in trauma to the spinal cord and nerve roots!
►Align and screw in the instruments, the pedicle screw and the polyaxial screw
only under X-ray control or using a navigation system.
WARNING
Risk of injury due to improper mounting of the locking screw!
►Position the locking screw correctly.
►Make certain that the rods are correctly positioned on the floor of the groove.
►Fully tighten the locking screw with the torque wrench.
►Break off the flanks only after fully tightening the locking screw (not for S4
element).
WARNING
Correction loss due to insufficient fixation of the implant head!
►Never loosen the connection of the implant head after it has been tightened.
►Tighten the locking screw only after every necessary corrective measure has
been performed.
WARNING
Risk of damage to the implant due to overtightening of the locking screw!
►Tighten the locking screw only with the exact torque specified for this purpose.
WARNING
Expansion of the implant head caused by tightening of the locking screw without
application of the countering instrument!
►Always use the countering instrument when tightening the locking screw.
WARNING
Damage to the implant caused by applying the reduction instruments too high at
the implant!
►Always apply reduction instruments (e.g. distraction and compression forceps)
below the rod at the implant.
WARNING
Expansion of the implant head caused by derotation without derotation sleeves!
►Always use derotation sleeves for rod derotation.
WARNING
Risk of damage to the implant caused by spondylolisthesis repositioning via the
locking screw!
►Always use the rod persuader for spondylolisthesis reposition.
WARNING
Inadequate fixation due to incorrect positioning of insert!
►When placing the rod, make certain that the insert is correctly positioned.
►After manipulating the rod, make certain that the insert is correctly posi-
tioned.
►After final locking, check that the insert is correctly positioned.
WARNING
Inadequate fixation due to incorrect positioning of the rod in the screw head, see
Fig.1-4!
►Adjust the curvature of the rod to the anatomical situation.
►Do not bend the rod in the region of the screw head.
►Make certain and check that the screw head is at right angles to the rod.
►Make certain and check that the rod is positioned securely in the groove base.
WARNING
Inadequate fixation due to incorrect rod position!
►Always position rods with hexagon and tip in such a way that the hexagon and
the tip is outside the implant head.
CAUTION
Rod connector is unusable if locking screws are removed or not present!
►Use another rod connector for implantation.
WARNING
Risk of injury if the locking screws are not fixed sufficiently!
►Make certain that there is no soft tissue caught in the rod connector.
►Position the rod connector correctly.
►Ensure that the rods have been completely inserted into the rod connector.
►Tighten up the locking screws with the 4 Nm torque wrench.
WARNING
Risk of danger if the locking screws are tightened too firmly or not firmly enough!
►Always tighten up the locking screws with the defined torque of 4 Nm.
WARNING
Inadequate fixation due to incorrect rod position!
►Always position the rod connector in such a way that the rod is completely
inserted into the rod connector.
►Always position rods in such a way that the end of the hexagon or tip of the
hexagon is located outside the clamping area of the rod connector.
WARNING
If soft tissue is caught in the rod connector, there is insufficient fixing!
►Make certain that there is no soft tissue caught in the rod connector.
►Remove soft tissue from the rod connector or select another rod connector for
implantation.
WARNING
If the screwdriver or torque wrench are used incorrectly, there is damage to the
hexagon socket in the locking screws.
►Ensure that the tip of the hexagon of the screwdriver or torque wrench when
tightening or loosening the locking screws is positioned entirely within the
hexagon socket of the locking screws.

de
Aesculap®
S4® Spinal System - Lumbar/Deformity
Legende
Fig. 1 S4monoaxiale Schrauben
Fig. 2 S4Element monoaxiale Schrauben
Fig. 3 S4polyaxiale Schrauben
Fig. 4 S4Element polyaxiale Schrauben
Zweckbestimmung
Die S4Spinal System-Implantate werden verwendet, um die lumbale und thorakale Wirbelsäule dorsal mono- und
multi-segmental zu stabilisieren. Sie bestehen aus:
■Mono- und Polyaxialschrauben
■Stäben
■Haken
■Querverbindern
■Stabverbindern – parallel, axial und lateral offset
■entsprechenden Befestigungselementen
Für die Implantation dieser Elemente sowie für die Distraktion, Kompression und Reposition der lumbalen und tho-
rakalen Wirbelsäule ist ein spezielles Instrumentarium zu verwenden.
Material
Die verwendeten Materialien der Implantate sind auf den Verpackungen angegeben:
■ISOTAN®FTitan-Schmiedelegierung Ti6Al4V gemäß ASTM F136/ISO 5832-3
■ISOTAN®PReintitan gemäß ASTM F67/ISO 5832-2
Titanimplantate sind mit einer farbigen Oxidschicht überzogen. Leichte Verfärbungen können vorkommen, haben
aber keinen Einfluss auf die Implantatqualität.
ISOTAN® ist ein eingetragenes Warenzeichen der Aesculap AG, 78532 Tuttlingen / Germany.
Indikationen
Operativ eingesetzte Implantate dienen der Unterstützung normaler Heilungsprozesse. Sie sollen weder normale
Körperstrukturen ersetzen noch im Falle nicht erfolgter oder verzögerter Heilung die auftretenden Belastungen dau-
erhaft übernehmen.
Verwenden bei schweren Wirbelsäulenleiden, die nicht durch konservativere Therapien behandelt werden können:
■Frakturen
■Pseudoarthrosen oder verzögerter Heilung
■Dislokation
■Degenerativen Instabilitäten
■Postdiskektomiesyndrom
■Spondylolisthesen
■Kyphosen
■Skoliosen
■Stenosen
■Posttraumatischen Instabilitäten
■Tumoren
■Osteoporose (bei gleichzeitiger Verwendung von Knochenzement und fenestrierten Schrauben)
Absolute Kontraindikationen
Nicht verwenden bei:
■Schwerwiegender Schädigung der Knochenstruktur an der Wirbelsäule, die einer stabilen Implantation der
Implantatkomponenten entgegenstehen könnte, wie z. B. Osteopenie, schwerer Osteoporose, Morbus Paget, Kno-
chentumoren etc.
■Metabolischen oder degenerativen Erkrankungen des Knochenstoffwechsels, die dazu führen können, dass eine
stabile Verankerung des Implantatsystems nicht gewährleistet ist
■Vermuteten Allergien oder Fremdkörperempfindlichkeiten auf die Implantatmaterialien
■Akuten oder chronischen Infektionen in der Wirbelsäule, lokaler oder systemischer Art
■Mangelnder Patientenmitarbeit oder eingeschränkter Fähigkeit, ärztlichen Anweisungen insbesondere in der
postoperativen Phase Folge zu leisten, einschließlich der Restriktionen hinsichtlich des Bewegungsumfangs
besonders in Bezug auf die Ausübung von Sport und beruflicher Aktivität
■Fällen, die nicht unter Indikationen genannt sind
Relative Kontraindikationen
Die Verwendung des Implantatsystems kann unter den folgenden Umstanden mit einem erhöhten klinischen Risiko
verbunden sein und bedarf einer genauen, individuellen Beurteilung durch den Chirurgen:
■Medizinische oder chirurgische Randbedingungen, die zu negativen Effekten auf den Erfolg der Implantation füh-
ren können, einschließlich Wundheilungsstörungen
■Randbedingungen, die zu einer übermäßigen Belastung der Wirbelsäule sowie der
■Implantate führen können, wie z. B. Schwangerschaft, Adipositas, neuromuskuläre Störungen oder Krankheit
■Schlechter Allgemeinzustand des Patienten, z. B. Drogensucht oder Alkoholismus
Neben- und Wechselwirkungen
Allgemeine Risiken eines chirurgischen Eingriffs werden als bekannt vorausgesetzt und sind deshalb in dieser
Gebrauchsanweisung nicht beschrieben. Mögliche Risiken, einschließlich daraus resultierender klinischer Folgen
bezüglich der Anwendung des Implantatsystems beinhalten, sind jedoch nicht beschränkt auf:
■Implantatversagen durch Überlastung
– Biegung
– Lockerung
–Bruch
■Mangelnde Stabilisierung, die eine erneute Operation zur Revision oder Entfernung des Implantatsystems erfor-
derlich macht
■Keine oder verspätete Fusion
■Infektion
■Wirbelkörperfraktur
■Gewebereaktionen auf die Implantatmaterialien
■Hämatome und Wundheilungsstörungen
■Verletzungen von
– Nervenwurzeln
– Rückenmark
– Gefäßen
–Organen
■Veränderungen der normalen Wirbelsäulenkrümmung
■Neurologische Beschwerden, einschließlich Fehlfunktionen des gastrointestinalen, urologischen und/oder Fort-
pflanzungssystems
■Schmerzen oder Unwohlsein
■Bursitis
■Abnahme der Knochendichte durch Belastungsvermeidung
■Knochenschwund/-bruch ober- oder unterhalb des versorgten Wirbelsäulenbereichs
■Eingeschränkte Leistungsfähigkeit
■Fortbestehen der durch die Implantation zu behandelnden Symptome
■Paresen
■Erneute Operation zur Entfernung des Implantatsystems
■Metallüberempfindlichkeit oder Fremdkörperallergie
■Risse in der Dura
■Meningitis
Sicherheitshinweise
■Der Operateur trägt die Verantwortung für die sachgemäße Durchführung des operativen Eingriffs.
■Allgemeine Risiken eines chirurgischen Eingriffs sind in dieser Gebrauchsanweisung nicht beschrieben.
■Der Operateur muss sowohl theoretisch als auch praktisch die anerkannten Operationstechniken beherrschen.
■Der Operateur muss mit der Knochenanatomie, dem Verlauf der Nerven und Blutgefäße, der Muskeln und Sehnen
absolut vertraut sein.
■Der Operateur ist für die Zusammenstellung der Implantatkomponenten und deren Implantation mit oder ohne
Knochenzement verantwortlich.
■Aesculap ist nicht verantwortlich für Komplikationen durch falsche Indikationsstellung, Implantatauswahl, fal-
sche Kombination von Implantatkomponenten und Operationstechnik sowie Grenzen der Behandlungsmethode
oder fehlende Asepsis.
■Die Gebrauchsanweisungen der einzelnen Aesculap-Implantatkomponenten und Instrumente müssen beachtet
werden.
■Die Testung und Zulassung der Implantatkomponenten erfolgte in Kombination mit Aesculap-Komponenten. Für
abweichende Kombinationen trägt der Operateur die Verantwortung.
■Implantatkomponenten unterschiedlicher Hersteller dürfen nicht kombiniert werden.
■Beschädigte oder operativ entfernte Implantatkomponenten dürfen nicht verwendet werden.
■Implantate, die einmal verwendet worden sind, dürfen nicht wieder verwendet werden.
■Bei verspäteter Heilung kann es durch Metallermüdung zum Bruch des Implantats kommen.
■Der behandelnde Arzt entscheidet über die Entfernung der eingesetzten Implantatkomponenten.
■Schäden an den gewichttragenden Strukturen des Implantats können das Lösen der Komponenten, Dislokation
und Migration sowie andere schwere Komplikationen verursachen.
■Um derartige Fehlerquellen möglichst frühzeitig zu erkennen, muss der Zustand der Implantatversorgung perio-
disch durch geeignete Maßnahmen überprüft werden.
■In der Patientenakte müssen die verwendeten Implantatkomponenten mit Artikelnummern, Implantatbezeich-
nung sowie Lot und ggf. Seriennummern dokumentiert werden.
■In der postoperativen Phase ist neben Bewegungs- und Muskeltraining besonders auf die individuelle Informa-
tion des Patienten zu achten.
Sterilität
■Die Implantatkomponenten werden unsteril geliefert.
■Die Implantatkomponenten sind einzeln verpackt.
►Implantatkomponenten in der Originalverpackung lagern und erst unmittelbar vor der Aufbereitung aus der Ori-
ginal- und Schutzverpackung nehmen.
►Zur Reinigung/Desinfektion reinigungsgerechten Siebkorb verwenden.
►Sicherstellen, dass die Implantatkomponenten in den Implantatsystemlagerungen nicht miteinander oder mit
Instrumenten in Kontakt kommen.
►Sicherstellen, dass die Implantatkomponenten keinesfalls beschädigt werden.
Vor der ersten Sterilisation und vor der Resterilisation müssen die Implantatkomponenten mit folgendem validiertem
Aufbereitungsprozess gereinigt werden:
Hinweis
Nationale gesetzliche Vorschriften, nationale und internationale Normen und Richtlinien und die eigenen Hygiene-
vorschriften zur Aufbereitung einhalten.
Hinweis
Bei Patienten mit Creutzfeldt-Jakob-Krankheit (CJK), CJK-Verdacht oder möglichen Varianten bezüglich der Aufbe-
reitung der Produkte die jeweils gültigen nationalen Verordnungen einhalten.
Hinweis
Es ist zu beachten, dass die erfolgreiche Aufbereitung dieses Medizinprodukts nur nach vorheriger Validierung des
Aufbereitungsprozesses sichergestellt werden kann. Die Verantwortung hierfür trägt der Betreiber/Aufbereiter.
Zur Validierung wurde die empfohlene Chemie verwendet.
Hinweis
Aktuelle Informationen zur Aufbereitung und zur Materialverträglichkeit siehe auch Aesculap Extranet unter
https://extranet.bbraun.com
Das validierte Dampfsterilisationsverfahren wurde im Aesculap-Sterilcontainer-System durchgeführt.
Validiertes Aufbereitungsverfahren
WARNUNG
Gefahr von Schraubenbrüchen durch Verwendung von Pedikelschrauben bei einer
Spondylolisthesis!
►Stabilisierung mit einer interkorporellen Fusion (ALIF, PLIF oder TLIF) unter-
stützen.
WARNUNG
Das Implantat wurde nicht auf Sicherheit und Kompatibilität in MR-Umgebungen
untersucht. Es wurde nicht auf Erwärmung, Bewegungen oder Bildartefakte bei
MR-Untersuchungen getestet. Das MR-Scannen eines Patienten mit diesem
Implantat kann zu Verletzungen des Patienten führen.
WARNUNG
Gefährdung der Resterilisierbarkeit durch intraoperative Verunreinigung mit Blut,
Sekreten und Flüssigkeiten!
►Zum Anreichen der Implantate neue Handschuhe verwenden.
►Implantatsystemlagerungen abgedeckt oder verschlossen halten.
►Implantatsystemlagerungen getrennt von Instrumenten-Siebkörben entsorgen.
►Unverschmutzte Implantate dürfen nicht gemeinsam mit verschmutzten Inst-
rumenten gereinigt werden.
►Wenn keine Implantatsystemlagerungen verfügbar sind, Implantatkomponen-
ten einzeln und getrennt aufbereiten. Dabei sicherstellen, dass die Implantat-
komponenten nicht beschädigt werden.
►Intraoperativ verschmutzte Implantate nicht wieder verwenden.
WARNUNG
Gefährdung der Resterilisierbarkeit durch direkte oder indirekte Kontamination!
►Implantate nach direkter oder indirekter Kontamination mit Blut nicht wieder
aufbereiten.