Johnson & Johnson DePuy Synthes EXPEDIUM User manual

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0086
0902-90-067 Rev. E
en
EXPEDIUM® Fenestrated Screw System
Instructions for Use
IMPORTANT INFORMATION
Please Read Before Use
INDICATIONS FOR USE
The EXPEDIUM
® Fenestrated Screw System is intended to be
used with the CONFIDENCE SPINAL CEMENT SYSTEM
® or the
V-MAX™ Mixing and Delivery System and the VERTEBROPLASTIC
®
Radiopaque Resinous Material or the VERTECEM V+ Cement Kit
to provide immobilization and stabilization of spinal segments in
the treatment of acute and chronic instabilities or deformities of
the thoracic, lumbar and sacral spine in patients with diminished
bone quality (e.g., osteoporosis, osteopenia, metastatic disease).
It is intended to provide temporary internal support and fixation
while fusion mass is consolidating or fracture is healing, or for the
palliative reconstruction of the tumor patients.
CONTRAINDICATIONS
The use of EXPEDIUM Fenestrated Screw System is contraindi-
cated in patients presenting with any of the following conditions:
•Disease conditions that have been shown to be safely and
predictably managed without the use of internal fixation devices
•Acute compromise of the vertebral body or walls of the pedicles
and disruption of the posterior cortex
•Anatomical damage of the vertebra that prevents safe screw
implantation
•Active or incompletely treated infection
•Coagulation disorders or severe cardiopulmonary disease
•Haemorrhagic diasthesis
•Spinal stenosis > 20% caused by retropulsed fragments
•Vertebral body collapse to less than 1/3 (33%) original height
•Coagulopathy or inability to reverse anti-coagulant therapy
(both during and approximately 24 hours post-procedure)
•Allergic reaction to any of the components of the cement or
metal used
•Relative contraindications include obesity, certain degenerative
diseases, and foreign body sensitivity. In addition, the patient’s
occupation or activity level or mental capacity may be relative
contraindications to this surgery. Specifically, patients who
because of their occupation or lifestyle, or because of conditions
such as mental illness, alcoholism, or drug abuse, may place
undue stresses on the implant during bony healing and may be
at higher risk for implant failure.
DESCRIPTION
The EXPEDIUM Fenestrated Screw System consists of Fenestrated
Screws and Clip-on Delivery System (includes a Cement Cannula
and a Clip). The EXPEDIUM Fenestrated Screw is a cannulated
polyaxial screw with fenestrations at the distal end of the screw
that are designed for cement introduction. The EXPEDIUM
Fenestrated Screw is designed for use in open and percutaneous
approaches and comes in a variety of sizes and lengths. It is
compatible for use with EXPEDIUM Spine Systems and VIPER
®
and VIPER
®
2 Spine Systems.
The EXPEDIUM Fenestrated Screw System can be used either
with the CONFIDENCE SPINAL CEMENT SYSTEM, or the
V-MAX Mixing and Delivery Device and the VERTEBROPLASTIC
Radiopaque Resinous Material, or the VERTECEM V+ Cement Kit.
When used with the CONFIDENCE SPINAL CEMENT SYSTEM,
EXPEDIUM Fenestrated Screw Cement Cannula must be
attached to the CONFIDENCE Spinal Cement Delivery System.
When used with the V-MAX Mixing and Delivery Device with the
VERTEBROPLASTIC Radiopaque Resinous Material, or the
VERTECEM V+ Cement, a CONFIDENCE Needle Adapter
(sold separately as an accessory to CONFIDENCE Spinal Cement
System) must be used to attach the V-MAX Flexible Tubing luer
lock to the Clip-on Delivery System.
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WARNINGS AND CAUTIONS
These instructions are provided for the processing of heat-
resistant, immersible, critical medical devices, unless otherwise
noted on specific product inserts. Product specific inserts are
given priority over these instructions. This can include heat-
sensitive devices and certain power (air- or electric-driven) tool
designs that are provided with specific cleaning and sterilization
instructions. Consult the product specific instructions for
processing in these cases.
The instructions provided are given as guidance for medical
device processing and have been validated by the manufacturer.
It is the responsibility of the healthcare facility to ensure that
processing is performed using the required equipment, materials
and personnel at a defined processing area. This will include the
handling of devices during transportation, processing and storage
prior to surgical use.
Those using these instructions should be qualified personnel with
documented training and competency in accordance with local
procedures, guidelines, and standards.
Surgically used instruments can be considered biohazard and
facilities should ensure that transport and handling procedures
comply with local regulations and guidelines.
Sterile, single use implants must not be reused or reprocessed.
Sterile implants are labelled as single use and have not been
validated for reprocessing.
Non-sterile implants must be processed prior to use in accordance
with these processing instructions. They must be discarded
following patient use.
Reusable, non-sterile surgical instruments are required to be
cleaned, inspected and sterilized prior to surgical use.
Care should be taken in the handling and cleaning of
sharp devices.
All devices must be thoroughly cleaned and inspected prior
to sterilization. Long, narrow lumens, blind holes, moving
and intricate parts require particular attention during cleaning
and inspection. During cleaning, only use detergents that are
labelled for use on medical devices and in accordance with the
manufacturer’s instructions. Cleaning agents with a used dilution
pH of within 7–9 are recommended. Highly alkaline conditions
(pH>10) can damage components/devices, in particular aluminum
materials. Do not use saline, environmental disinfection (including
chlorine solutions) or surgical antiseptics (such as iodine- or
chlorhexidine-containing products). Do not use a cleaning aid
that can damage the surface of instruments such as steel wool,
abrasive cleaners or wire brushes.
Instruments should be carefully inspected before each use to
ensure that they are functional. Scratches, dents or other damage
can result in instrument breakage or tissue injury.
Instruments must be cleaned separately from instrument trays
and cases. Instrument trays and cases are designed as an
organizational tool in preparation for sterilization, storage and
surgical use. Non-sterile implant sets may be processed in their
trays provided
Automated equipment, including washer-disinfectors and
steam sterilizers must be installed, maintained and operated in
accordance with manufacturer’s instructions.
Do not exceed 140
° C (284 ° F) during reprocessing steps.
For patients with, or suspected with, Creutzfeldt-Jakob disease
(CJD), variant CJD or other transmissible spongiform encephalop-
athy (TSE) and related infections, it is recommended to treat the
patient using single-use instruments. Safely dispose of all devices
used in accordance with local procedures and guidelines.
LIMITATIONS ON PROCESSING
Repeated processing cycles in compliance with these instructions
for use have minimal effects on device life and function.
Instruments do not have an indefinite functional life. End of life
of devices is determined by wear and damage due to surgical
use and handling. Evidence of damage and wear on a device
may include but is not limited to corrosion (i.e. rust, pitting),
discoloration, excessive scratches, flaking, wear and cracks.
Improperly functioning devices, devices with unrecognizable
markings, missing or removed (buffed off) part numbers,
damaged and excessively worn devices should not be used.
Non-sterile implants must be discarded following patient use.
Any implant with evidence of damage, such as due to handling or
processing must be discarded.
Step 1: Point of Use Care
•Ensure that no instruments or parts are left in the surgical site
prior to closure as patient injury may result.
•All single use devices and materials should be removed and
discarded in compliance to local policies.
•The drying of gross soil (blood, tissue and/or debris) on
devices following surgical use should be avoided. It is preferred
that gross soil is removed from devices following use and in
preparation for transportation to a processing area. Gross
soil can be removed using sponges, cloths, or soft brushes.
Water and/or cleaning detergents (labelled for use on medical
devices) may be used.
•Do not use saline, environmental disinfection (including
chlorine solutions) or surgical antiseptics (such as iodine) or
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chlorhexidine-containing products. Flush all lumened devices
with water (or detergent solution) to prevent the drying of soil
and/or debris to the inside.
•If gross-soil cannot be removed at the point of use, the devices
should be transported to prevent drying (e.g., covered with a
towel dampened with purified water) and cleaned as soon as
possible at a designated processing area.
•Surgical cement should be removed from devices during
surgical use and prior to setting. When cement hardens it
will typically require physical methods to remove. Chemical
solvents should not be used. Hardened cement may be
removed with an approved stylus or removing tool, but these
may damage devices.
Step 2: Containment and Transportation
•Surgically used devices may be considered bio-hazardous and
should be safely transported to a designated processing area in
accordance with local policies.
Step 3: Cleaning
Preparation before Cleaning
•It is recommended that devices should be reprocessed as soon
as is reasonably practical following surgical use.
•Instruments must be cleaned separately from instrument trays
and cases
•Non-sterile implants may be cleaned and disinfected in the
provided implant trays.
•Care should be taken in the handling and cleaning of sharp
devices. These are recommended to be cleaned separately to
reduce risks of injury.
•Multi-part or complex instruments may require disassembly for
cleaning. Refer to any technique guides or other supplemental
information for specific device disassembly and/or reassembly
instructions.
•Any devices with moving parts (e.g. ratchets, box locks, hinges
or actuated parts) need to be actuated during cleaning to
ensure access of the cleaning process.
•All devices with lumens need to be manually cleaned. Lumens
should be flushed to remove debris and brushed thoroughly
using appropriately sized soft-bristled brushes and twisting
action. Brush size should be approximately the same diameter
of the lumen to be cleaned. Using a brush that is too big or
too small for the diameter of the lumen/cannulation may not
effectively clean the lumen. Refer to any technique guides
or other supplemental information for specific device lumen
diameters. After brushing, rinse with water by flushing and blow
clean compressed air through all lumens.
NOTE: Two cleaning methods are provided, a Manual and an
Automated Method, and at least one shall be performed.
Cleaning: Manual
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be ≤40
° C (104 ° F) for
manual cleaning.
NOTE: The cleaning solution may contain enzymes.
Aluminum-safe alkaline cleaners can be used, but can vary
in material compatibility overtime based on their formulation.
Material compatibility should be confirmed with the detergent
manufacturer.
2. Immerse devices and parts in the detergent solution, and
soak for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly clean all traces
of blood and debris from all device surfaces for at least
one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute.
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution,
if applicable. Ensure all lumens are flushed for at least
one minute.
6. Remove the devices and completely submerge in an ultrasonic
bath prepared with a neutral or mild alkaline pH detergent
(pH 7-9), prepared in accordance with the manufacturer’s
instructions. Use a large syringe (50ml or greater) flush all
lumens with the cleaning solution, articulating areas, and
flexible segments with the detergent solution to minimize the
formation of air pockets or bubbles.
NOTE: Ultrasonic cleaning is only effective if the surface to be
cleaned is immersed in the cleaning solution. Air pockets will
decrease the efficacy of ultrasonic cleaning.
7. Ultrasonically clean the device components for a minimum of
10 minutes.
8. Rinse all devices by immersion in ambient, < 40
° C (104 ° F),
tap water for a minimum of one minute and until visual
evidence of debris, soil, and cleaning solution are gone. Use a
large syringe (e.g., 50ml or greater) filled to capacity with tap
water to thoroughly flush lumens and channels. Actuate joints,
handles and other moveable device features in order to rinse
thoroughly.
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9. Remove the devices and repeat the rinsing using in ambient,
< 40
° C (104 ° F) critical water (high purity water generated by
processes such as RO, deionization or distillation) for at least
15 seconds.
10. Remove and dry device using a clean, soft, lint-free cloth or
clean compressed air. Ensure that all lumens and articulated
areas are dried using compressed air.
Cleaning: Automated
1. Prepare a neutral or mild alkaline cleaning solution (pH 7 to 9)
in accordance to the detergent manufacturer’s instructions.
The temperature of the solution should be ≤40
° C (104 ° F) for
manual cleaning.
NOTE: The cleaning solution may contain enzymes. Aluminum-
safe alkaline cleaners can be used, but can vary in material
compatibility overtime based on their formulation. Material com-
patibility should be confirmed with the detergent manufacturer.
2. Immerse devices and parts in the detergent solution, and soak
for a minimum of 5 minutes.
3. While immersed, use a soft non-metallic bristle brush (plastic
bristles, like nylon) or sponge to thoroughly scrub all traces of
blood and debris from all device surfaces for at least one minute.
4. Ensure all lumens are thoroughly brushed. Push the brush
through the entire length of the lumen using a twisting motion
to remove debris from both ends for at least one minute
5. During cleaning, actuate joints, handles and other movable
device features to expose all areas to the detergent solution, if
applicable. Ensure all lumens are flushed for at least one minute.
6. Load the device components in the washer-disinfector in
accordance with manufacturer’s instructions, ensuring that the
devices and lumens can drain freely.
7. Automated washing shall be conducted in a validated washer-
disinfector in compliance to ISO 15883-1 and-2, or to an
equivalent standard. Automated washing can be included as
part of a validated washing, disinfection, and/or drying cycle
in accordance to manufacturer’s instructions. An example of a
validated cycle used for cleaning validation include:
Phase Recirculation Time Water Temp Detergent/Water Type
Pre-wash 2:00 Cold Tap
Water N/A
Enzyme
wash 1:00 < 40
° C
(104
° F) Neutral, Enzymatic Cleaner
Wash 5:00 66
° C
(151
° F) Neutral pH Detergent
Phase Recirculation Time Water Temp Detergent/Water Type
Rinse 2:00 > 40
° C
(104
° F) Tap water
Rinse 0:15 Ambient Critical water (RO, deionized or
distilled water)
Step 4: Thermal Disinfection
Thermal disinfection is recommended to render devices safe for
handling prior to steam sterilization. Thermal disinfection should
be conducted in a washer-disinfector compliant to ISO 15883-1
and-2, or to an equivalent standard. Thermal disinfection in
the washer-disinfector shall be validated to provide an A0of at
least 600 (e.g., 90
° C (194 ° F) for 1 min). Higher levels of A0can
be achieved by increasing the exposure time and temperature
(e.g., A0of 3000 at >90
° C (194 ° F) for 5 min, in accordance
with local requirements). Load the device components in the
washer-disinfector in accordance with manufacturer’s instructions,
ensuring that the devices and lumens can drain freely. Lumened
devices should be placed in a vertical position. If this is not
possible due to space limitations within the washer-disinfector,
use an irrigating rack /load carrier with connections designed
to ensure an adequate flow of process fluids to the lumen or
cannulation of the device if provided.
The following automated cycles are examples of validated cycles:
Phase Recircula- tion Time Water Temp Water Type
Thermal
Disinfection 1:00 > 90
° C
(194
° F)
Critical water
(RO, deionized or
distilled water)
Thermal
Disinfection 5:00 > 90
° C
(194
° F)
Critical water
(RO, deionized or
distilled water)
Step 5: Drying
It is recommended that drying is conducted in a washer-disinfector
compliant to ISO 15883-1 and-2, or to an equivalent standard.
Drying efficiency in washer-disinfectors can range considerably
based on the automated system design and load configuration.
The following automated cycle is an example of a validated cycle:
Phase Recirculation Time Air Temp Air Type
Dry 7:00 115
° C (239 ° F) Medical grade
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Following automated drying, inspect the device for residual
moisture. Any residual moisture identified should be dried
manually (as described below).
For manual drying:
•Ensure each device is dried and inspected thoroughly.
•For external surfaces, use a clean, soft, lint-free cloth to avoid
damage to the surface.
•Open and close any applicable devices during drying. Pay
special attention to any device threads, ratchets and hinges or
areas where fluid can accumulate. Clean, compressed air (e.g.,
medical grade) may be used to facilitate surface drying.
•Dry all lumen/cannulated parts using clean compressed air
(e.g., medical grade).
Step 6: Maintenance and Inspection
Instruments should be visually inspected under ambient lighting,
to verify that the devices do not have visible soil, damage or
moisture.
Inspect devices for:
•Lack of moisture. If moisture is detected, manually drying
should be performed.
•Cleanliness. If any residual soil is discovered during inspection,
repeat the cleaning steps on those devices until all visible soil is
removed from the device.
•Damage, including but not limited to, corrosion (rust, pitting),
discoloration, excessive scratches, flaking, cracks and wear
•Proper function, including but not limited to, sharpness of
cutting tools, bending of flexible devices, movement of hinges/
joints/box locks and moveable features such as handles,
ratcheting and couplings and missing or removed part numbers
Improperly functioning devices, devices with unrecognizable
markings, missing or removed (buffed off) part numbers,
damaged and worn devices should be discarded.
Disassembled devices should be reassembled prior to sterilization
when specified.
Lubricate any moving parts with a water-soluble surgical
instrument lubricant. The lubricant should be approved for use on
medical devices and provided with data to ensure biocompatibility
and compatibility with steam sterilization.
Step 7: Packaging
Place cleaned, dry devices into the specified locations within the
cases provided, if applicable.
Only legally marketed, and locally approved sterilization barriers
(e.g. wraps, pouches or containers) should be used for packaging
terminally sterilized devices, in compliance to the manufacturer’s
instructions.
Step 8. Sterilization
Steam (moist heat) sterilization shall be performed in a locally
approved, pre-vacuum (forced air removal) cycle. The steam
sterilizer should be validated to the requirements of any local
standards and guidance such as EN 285 or AAMI/ANSI ST8. The
steam sterilizer should be installed and maintained in compliance
to manufacturer’s instructions and local requirements. Ensure
that the steam sterilizer cycle is chosen that is designed to
remove air from porous or lumened device loads in accordance
to manufacturer’s instructions and does not exceed the criteria for
sterilizer load.
The following steam sterilization cycles are examples of validated
cycles:
Condition-
ing Phase
Minimum Steril-
ization Exposure
Time (minutes)
Minimum
Sterilization
Exposure
Temperature Dry Time
*
Prevacuum 4132 ° C (270 ° F) 30 minutes
Prevacuum 3134
° C (274 ° F) 30 minutes
Extended steam exposure cycle can be used to meet local
requirements such as 134
° C (274 ° F) for 18 minutes.
The efficiency of steam sterilizer drying can range considerably
depending on the sterilizer design, loading, packaging and steam
supply during the sterilization process. The user should employ
verifiable methods (e.g. visual inspections) to confirm adequate
drying. Extended drying within the sterilizer or in an external
drying cabinet in accordance with manufacturer’s instructions may
be necessary. Do not exceed 140
° C (284 ° F) during drying.
Step 9: Storage
Sterilized products should be stored in a dry, clean environment,
protected from direct sunlight, pests, and extremes of temperature
and humidity.
Refer to sterilization wrap or rigid container manufacturer’s IFU for
limits on sterile product storage time and storage requirements for
temperature and humidity.
ADDITIONAL INFORMATION
Cleaning agent information: Examples of detergents that have
been used during cleaning validations include ProlysticaTM
2X Concentrate Enzymatic Cleaner, ProlysticaTM 2X Neutral
Detergent, EnzolTM, EndozimeTM, Neodisher MedizymTM,
Terg-A-ZymeTM, and NpH-KlenzTM.
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These instructions for use have been validated in accordance with
ISO 17664. It remains the responsibility of the facility to ensure
that the processing is actually performed using equipment, materials
and personnel at a designated area, and achieves the desired
requirements. This includes validation and routine monitoring of
the process. Likewise, any deviation by the processor from these
recommendations should be evaluated for effectiveness and any
potential adverse consequences.
All personnel using these instructions should be qualified with
documented expertise, competency and training. Users should be
trained on healthcare facility policies and procedures along with
current applicable guidelines and standards.
ADVERSE EVENTS
1. Serious adverse events, some with fatal outcome, associated
with the use of acrylic bone cements in the spine include
myocardial infarction, cardiac arrest, cerebrovascular accident,
pulmonary embolism, and cardiac embolism. Although the
majority of these adverse events present early within the post-
operative period, there have been some reports of diagnoses
beyond a year or more after the procedure.
2. Other reported adverse events for acrylic bone cements
intended for use in the spine include: Leakage of the bone
cement beyond the site of its intended application with
introduction into the vascular system resulting in embolism of
the lung and/or heart or other clinical sequelae.
3. Bending or fracture of implant.
4. Loosening of the implant. Screw back out, possibly leading to
implant loosening, and/or reoperation for device removal.
5. Metal sensitivity or allergic reaction to a foreign body.
6. Superficial or deep wound infection, early or late.
7. Nonunion, delayed union.
8. Decrease in bone density due to stress shielding.
9. Pain, discomfort, or abnormal sensations due to the presence
of the device.
10. Nerve damage due to surgical trauma or presence of the
device. Neurological difficulties including bowel and/or
bladder dysfunction, impotence, retrograde ejaculation, and
paraesthesia.
11. Bursitis.
12. Paralysis.
13. Dural tears experienced during surgery could result in the
need for further surgery for dural repair, a chronic CSF leak or
fistula, and possible meningitis.
14. Adverse tissue reaction. Possible local or systemic adverse
reactions from potential long-term degradation of cement with
the mechanical grinding causing wear debris.
15. Vascular damage due to surgical trauma or presence of the
device. Vascular damage could result in catastrophic or fatal
bleeding. Malpositioned implants adjacent to large arteries
or veins could erode these vessels and cause catastrophic
bleeding in the late postoperative period. Also local vascular
erosion and occlusion may result due to cement use.
16. Damage to lymphatic vessels and/or lymphatic fluid exudation.
17. Spinal cord impingement or damage.
18. Fracture of bony structures. Fracture, degenerative changes
or instability in segments adjacent to fused vertebral levels.
19. Pulmonary embolism which may result in death. Cement, fat
or air emboli.
20. Anaphylaxis. Allergic pyrexia.
21. Transitory fall in blood pressure. Hypertension
or hypotension.
22. Thrombophlebitis.
23. Hemorrhage and hematoma.
24. Cardiac arrythmia.
25. Heterotopic bone formation.
26. Hypoxemia.
27. Bronchospasm.
28. Pain and/or loss of function. Transitory worsening of pain due
to heat released during cement polymerization.
29. Hematuria or Dysuria.
30. Bladder fistula.
31. Local neuropathy.
32. Nerve entrapment and dysphagia due to extrusion of the bone
cement beyond its intended application.
33. Intestinal obstruction because of adhesions and stricture of
the ileum due to heat released during polymerization.
Please refer to the package inserts for the CONFIDENCE SPINAL
CEMENT SYSTEM, the CONFIDENCE Spinal Cement, the
V-MAX Mixing and Delivery Device , the VERTEBROPLASTIC
Radiopaque Resinous Material and the VERTECEM V+ Cement
Kit for adverse events associated with the cement use.
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WARNINGS
1. Refer to the EXPEDIUM Spine System package insert for
warnings associated with the use of EXPEDIUM Spine System.
2. Depending on the cement used, refer to the package inserts
of the CONFIDENCE SPINAL CEMENT SYSTEM Kit and
the CONFIDENCE Spinal Cement, the VERTEBROPLASTIC
Radiopaque Resinous Material, or the VERTECEM V+
Cement Kit for a list warnings associated with the cement use.
Follow the time temperature chart for mixing, delivery and
setting time of the cement used very carefully.
3. The EXPEDIUM Fenestrated Screws should NOT be placed
bicortically. It is very important not to breach the pedicle wall
or the anterior cortex of the vertebral body to avoid cement
extrusion into the retroperitoneal space. This may result
in serious complications, including cement extravasation,
embolism or even death, especially if the cement is
inadvertently delivered through the tip of the screw.
4. Pay special attention to the delivery system instructions
from the corresponding package insert. Aggressive cement
injection may result in cement leakage or extravasation.
5. Accurate pedicle preparation, screw sizing and placement must
be practiced, as well as a careful cement delivery technique.
There may be an increased risk of cement egress into pedicle
if the screw length is too short for the vertebral body, or if
excessive cement volume is pumped into the vertebral body.
6. Some literature suggests that the amount of cement delivered
per pedicle should not exceed 2cc in order to reduce the
occurrence of cement extravasation, and that the larger
volume of cement delivered does not necessarily improve
screw pull out or other outcomes. Some literature suggests
that the increase in the total amount of cement injected using
any PMMA cement may be associated with an increased risk
of circulatory complications.
7. When using cement to augment multiple screws or levels,
attention must be paid not to exceed the working time of the
cement prior to completion of cement delivery through the
screw. When the cement working time is close to completion,
a new cement package should be opened to mix and deliver
cement through the next screw/level.
8. It is critical that NO torsion movement should be applied to
the screw after injecting the cement in order to avoid breaking
the cement bridges between screw and bone.
9. Do not continue injection beyond the working time of the
cement. After cement introduction is complete, the EXPEDIUM
Fenestrated Screw Cement Cannula and Clip must be
removed immediately. The cement setting while the cannula
and clip are still connected to the screw may lead to difficulty
in removal of these items, and a new cannula and clip may be
required for additional levels.
10. Strict adherence to good surgical principles and techniques
is essential. Deep wound infection is a serious post-operative
complication and may require total removal of the embedded
cement. Deep wound infection may be latent and may not
manifest itself even for several years post-operatively.
11. Hypotensive reactions may occur with any procedure that
involves cement use and some may progress to cardiac
arrest. For this reason, patients should be monitored for any
change in blood pressure during and immediately following
the application of the cement.
12. Following cement introduction, positioning of the patient
should be maintained securely throughout the setting phase
as described in package inserts for either the CONFIDENCE
SPINAL CEMENT SYSTEM, the VERTEBROPLASTIC
Radiopaque Resinous Material, or the VERTECEM V+
Cement Kit depending on which cement was used.
13. The long-term safety and efficacy of the EXPEDIUM
Fenestrated Screw System with cement augmentation have
not yet been established.
14. The safety and efficacy of the EXPEDIUM Fenestrated Screw
System in pregnant women or in children has not yet been
established.
15. Cement leakage may cause tissue damage, nerve or circulatory
problems, and other serious adverse events. These risks may
increase with the number of spinal levels where cement is
utilized, and also with the volume of spine cement used.
PRECAUTIONS
1. The implantation of pedicle screw spinal systems should be
performed only by experienced spinal surgeons with specific
training in the use of this pedicle screw spinal system because
this is a technically demanding procedure presenting a risk of
serious injury to the patient. The surgeon must be thoroughly
knowledgeable not only in the medical and surgical aspects
of the implant, but must also be aware of the mechanical
and metallurgical limitations of metallic surgical implants.
The surgeon should also be familiar with the principles and
technique of spinal cement delivery, including possible side
effects and limitations, and with the physiology and pathology
of the selected anatomy.
2. A thorough pre-operative check-up of the patient must be
carried out before the operation.
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3. Postoperative care is extremely important. The patient must
be instructed in the limitations of the metallic implant and be
warned regarding weight bearing and body stresses on the
appliance prior to firm bone healing. The patient should be
warned that noncompliance with postoperative instructions
could lead to failure of the implant and possible need thereafter
for additional surgery to remove the device.
4. During the application of the cement, radiological control is
essential so that the operator can follow the progress of the
filling and stop the procedure if the slightest leakage of cement
is detected. Use appropriate imaging techniques such as
fluoroscopy or CT imaging guidance to confirm correct needle
placement, absence of damage to surrounding structures
and appropriate location of injected cement. Imaging, such
as venography, may also be used to assess the ability of the
vertebra to contain the injected cement.
5. If surgeon chooses to complete a biopsy prior to screw
placement, care should be taken not to place the tip of the
biopsy needles beyond the desired location of the screw tip in
order to reduce leakage or extravasation risk.
6. EXPEDIUM Fenestrated Screws System implants and
instruments must never be reused. An explanted implant
should never be reimplanted. Even though a device appears
undamaged after explanting, it may have small defects and
internal stress patterns that may lead to early breakage. Reuse
of single use implants and instruments may compromise
instrument performance and patient safety and can also cause
cross-contamination leading to patient infection.
PROCEDURE
CAUTION: It is essential to maintain strict sterile technique
during the procedure and during all phases of handling
this product.
1. Place each EXPEDIUM Fenestrated Screw into the pedicle
per the EXPEDIUM Spinal System Surgical Technique
Manual for proper screw insertion steps. It is critical that
NO torsion movement should be applied to the screw after
injecting the cement).
2. Thread the Cannula into the Clip.
3. Mix the spinal cement of choice (CONFIDENCE Spinal
Cement, VERTEBROPLASTIC Radiopaque Resinous Material
or VERTECEM V+ Cement) per the instructions provided in
the package inserts. Follow the time temperature chart from
respective cement package insert very carefully not to exceed
the working time.
4. If CONFIDENCE Spinal Cement is used, CONFIDENCE
Spinal Cement Delivery System must be attached to the
threaded connection of the EXPEDIUM Fenestrated Screw
Clip-on Delivery Device (Cannula and Clip). If V-MAX
Mixing and Delivery Device is used, it should be attached to
the CONFIDENCE Needle Adapter, which should then be
attached to the Clip-on Delivery Device.
5. Place the Clip-On Delivery Device through the screw head
and into the bone shank. Once the Cannula is inside the
shank, the Clip will engage the screw head.
6. Follow instructions from package inserts of the CONFIDENCE
SPINAL CEMENT SYSTEM, the V-MAX Mixing and Delivery
Device, or the VERTECEM V+ Cement Kit to introduce the
cement through the EXPEDIUM Fenestrated Screw Cannula.
7. Use Fluoroscopic or CT imaging guidance throughout the
procedure to verify and monitor cement flow as appropriate.
8. When the appropriate amount of cement has been introduced,
stop cement introduction as indicated per the manufacturers
technique. It is recommended not to exceed 2cc of cement
per pedicle in order to reduce the occurrence of cement
leakage and extravasation. Un-engage the Clip-On Delivery
Device from the screw head and remove it from the screw.
9. Place the Clip-on Delivery Device into the next screw per step
5, and follow steps 5-7 as working time permits (follow the
time temperature chart from respective cement package insert
very carefully not to exceed the working time).
10. Repeat this process for each screw if desired. Prior to the
completion of the working time, the Clip-on Delivery Device
should be removed from the screw, and a new Cannula
should be utilized with a new package of cement and cement
delivery system (either the CONFIDENCE SPINAL CEMENT
SYSTEM, the V-MAX Mixing and Delivery Device and the
VERTEBROPLASTIC Radiopaque Resinous Material, or the
VERTECEM V+ Cement Kit) for next levels (follow steps 3-7).
IMPORTANT PHYSICIAN INFORMATION
1. EXPEDIUM Fenestrated Screw System, like any other temporary
internal fixation devices, has a finite useful life. The patient’s
activity level has a significant impact on this useful life. Your
patient must be informed that any activity increases the risk of
loosening, bending, or breaking of the implant components.
It is essential to instruct patients about restrictions to their
activities in the postoperative period and to examine patients
postoperatively to evaluate the development of the fusion mass
and the status of the implant components. Even if solid bone
fusion occurs, implant components may nevertheless bend,
break, or loosen. Therefore, the patient must be made aware
that implant components may bend, break, or loosen even
though restrictions in activity are followed.
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2. Because of the limitations imposed by anatomic considerations
and modern surgical materials, metallic implants cannot be
made to last indefinitely. Their purpose is to provide temporary
internal support and fixation while fusion mass is consolidating
or fracture is healing, or for the palliative reconstruction of
the tumor patients. These types of implants are more likely to
fail if no bone graft is used, if a pseudarthrosis develops, or if
patients have severe or multiple preoperative curves.
3. The surgeon may remove these implants after bone fusion
occurs. In some cases, removal is indicated because the
implants are not intended to transfer or to support forces
developed during normal activities. The possibility of a second
surgical procedure must be discussed with the patient, and the
risks associated with a second surgical procedure must also
be discussed. If the implants do break, the decision to remove
them must be made by the physician who must consider
the condition of the patient and the risks associated with the
presence of the broken implant.
4. These devices are not intended or expected to be the only
mechanism for support of the spine. Regardless of the etiology
of the spinal pathology, for which implantation of these devices
was chosen, it is the expectation and requirement that a spinal
fusion or arthrodesis be planned and obtained. Without solid
biological support provided by spinal fusion, the devices can
not be expected to support the spine indefinitely and will fail
in any of several modes. These modes may include bone-
metal, bone-cement and cement-metal interface failure, implant
fracture, or bone failure.
5. The safety and effectiveness of pedicle screw spinal systems
have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with
instrumentation. These conditions are significant mechanical
instability or deformity of the thoracic, lumbar, and sacral spine
secondary to severe spondylolisthesis (grades 3 and 4) of the
L5-S1 vertebra, degenerative spondylolisthesis with objective
evidence of neurologic impairment, fracture, dislocation,
scoliosis, kyphosis, spinal tumor, and failed previous fusion
(pseudarthrosis). The safety and effectiveness of these devices
for any other conditions are unknown.
6. Until X-rays confirm the maturation of the fusion mass or
healed fracture, external immobilization (such as bracing or
casting) is recommended.
7. Instructions to the patient to reduce stress on the implants are
an equally important part of the attempt to avoid the occurrence
of clinical problems that may accompany fixation failure.
LIMITED WARRANTY AND DISCLAIMER
PRODUCTS FROM DEPUY SYNTHES PRODUCTS, INC. ARE
SOLD WITH A LIMITED WARRANTY TO THE ORIGINAL
PURCHASER AGAINST DEFECTS IN WORKMANSHIP AND
MATERIALS. ANY OTHER EXPRESS OR IMPLIED WARRANTIES,
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS,
ARE HEREBY DISCLAIMED.
IF MORE THAN TWO YEARS HAVE ELAPSED BETWEEN THE
DATE OF ISSUE/REVISION OF THIS INSERT AND THE DATE
OF CONSULTATION, CONTACT DEPUY SYNTHES SPINE
FOR CURRENT INFORMATION AT [phone] OR AT
[phone].
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MATERIAL
MATL
SYMBOL TRANSLATION
A/T ACROFLEX
®
/Ti
ACROFLEX
®
/Titanium
AAI
Aluminum
A/P Al/PL
Aluminum/Plastic
B/R Ba/RADEL
®
Barium/RADEL
®
Ba/PEEK
Barium Sulfate (BaSO
4
)/
PEEK Polymer
CaP
CALCIUM PHOSPHATE
Calcium Phosphate
CM CoCrMo
Cobalt Chromium
Molybdenum
CMTC
CoCrMo/Ti/CALCIUM
PHOSPHATE
Cobalt Chromium
Molybdenum/Titanium/
Calcium Phosphate
CoNiCrMo
Cobalt Nickel
Chromium Molybdenum
FFOAM
Foam
HA
Hydroxyapatite
NiTi Ni/Ti
Nickel/Titanium
PL
Plastic
SRSI
SS/RADEL
®
/SILICONE
Stainless Steel/RADEL
®
/
Silicone
SRSN
SS/RADEL
®/
SILICONE/Ti Al Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium
Aluminum Nitride
SS/RADEL
®/
SILICONE/Ti
Nitride
Stainless Steel/RADEL
®
/
Silicone/Titanium Nitride
SRTA
SS/RADEL
®
/Ti Al Nitride
Stainless Steel/RADEL
®
/
Titanium Aluminum Nitride
STA SS/Ti Al Nitride
Stainless Steel/
Titanium Aluminum Nitride
S/U SS/ULTEM
Stainless Steel/Ultem
TTi
Titanium and its alloys
S/R SS/RADEL
®
Stainless Steel/RADEL
®
R/T
POLYOLEFIN RUBBER/Ti
Polyolefin Rubber/Titanium
T/ATi/Al
Titanium/Aluminum
Ti/CoCrMo
Titanium/Cobalt
Chromium Molybdenum
P/F PL/FOAM
Plastic/Foam
PY
Polyester
PEEK/C
PEEK/CARBON
FIBER COMPOSITE
Polyether Ether Ketone/
Carbon Fiber Composite
PEEK OPTIMA®
Polyether Ether Ketone
PPOLYMER
Polymer
P/CM PE/CoCrMo
Polyethylene/Cobalt
Chromium Molybdenum
P/C
POLYMER/CARBON
FIBER COMPOSITE
Polymer/
Carbon Fiber Composite
Si/NITINOL
Silicone/Nitinol
SSS
Stainless Steel
S/A SS/Al
Stainless Steel/Aluminum
SBR SS/Ba/RADEL
®
Stainless Steel/Barium/
RADEL
®
S/P SS/PHENOLIC
Stainless Steel/Phenolic
S/PLSS/PL
Stainless Steel/Plastic
LOT LOT NUMBER
REF REF
CATALOG NUMBER
QTY QUANTITY
SZ SIZE
MADE IN MADE IN
NTI
NEURAL TISSUE
INSTRUMENT
IOM
NEUROMONITORING
INSTRUMENTS
Federal (USA) law
restricts this device
to sale by or on the
order of a physician
DO NOT RESTERILIZE
T2
T1
Lower Limit of
temperature
=
T1
Upper Limit of
temperature
=
T2
25°C
STORE AT ROOM
TEMPERATURE
KEEP AWAY FROM
SUNLIGHT
SINGLE USE
ATTENTION.
SEE INSTRUCTIONS
FOR USE
PACKAGE CONTAINS
FLAMMABLE LIQUID
DO NOT USE
IF PACKAGE IS
DAMAGED
MSR
MEASURING DEVICE
STERILE
STERILE
STERILE A
Sterile medical device
processed using
aseptic technique
STERILE R
STERILIZATION BY
IRRADIATION
STERILE EO
STERILIZATION BY
ETHYLENE OXIDE
LATEX FREE
LATEX FREE
NON
STERILE
NONSTERILE
NONSTERILE
MANUFACTURER
DATE OF
MANUFACTURE
US REP
US REPRESENTATIVE
EC REP
AUTHORIZED
EUROPEAN
REPRESENTATIVE
DIST
DISTRIBUTED BY
XXXX-XX
USE BY
Ti/HA
Titanium/Hydroxyapatite
Ti/UHMWPE/HA
Titanium/Ultra-High
Molecular Weight
Polyethylene/Hydroxyapatite
SS/Ti
Stainless Steel/Titanium
SS/Al/SILICONE
Stainless Steel/
Aluminum/Silicone
SS/SILICA GLASS
Stainless Steel/Silica Glass
SS/SILICA GLASS/
PL/SILICONE
Stainless Steel/Silica Glass/
Plastic /Silicone
SS/SILICA GLASS/
RADEL
®/SILICONE
Stainless Steel/Silica Glass/
RADEL
®
/Silicone
SS/SILICA GLASS/
SILICONE
Stainless Steel/
Silica Glass/Silicone
S/SISS/SILICONE
Stainless Steel/Silicone
SS/WC/SILICONE
Stainless Steel/Tungsten
Carbide/Silicone
W/C
Tungsten Carbide
2018-03-09 04:03:33