Download to the entire C-VBR Surgical Technique Documentation

Surgical Technique Guide
Cardinal Spine C-VBR
Cervical Vertebral Body Replacement (VBR)
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
1. IMPORTANT NOTES
Users of the Cardinal Spine C-VBR acknowledge that they have read and agree to the conditions in this insert.
Additional copies of this Surgical Technique Guide for C-VBR can be obtained from Cardinal Spine at the address
given at the end of this document.
2. GENERAL CONDITIONS OF USE
The safe implantation of any cervical vertebral body replacement (VBR) device requires an in-depth knowledge of
human anatomy as well as a specific patient’s anatomical variations. Implantation of the Cardinal Spine C-VBR
should be performed only by experienced spinal surgeons with specific training in these types of procedures and
knowledge of the mechanical and material limitations of this implant.
3. DESCRIPTION
C-VBR is generally a trapezoidal shaped device having trapezoidal cross sections and provided in a variety of sizes
to suit the individual anatomic and clinical circumstances of each patient. C-VBR is a single-piece device with a
hollow interior to accommodate the placement of autograft or allograft bone. Intended for placement via an anterior
approach, C-VBR is to be used in combination with supplemental fixation indicated for use in the cervical spine.
C-VBR implants with parallel endplates are provided with no endplate angulation. C-VBR implants with lordosis
end plates are provided with 9.6° or 11.5° of endplate angulation (lordosis). See Section 13 for the full range of sizes
available for C-VBR.
C-VBR is provided non-sterile to the end user (See also Sections 14-16).
C-VBR is intended for use with supplemental internal fixation indicated for use in the cervical spine. The
supplemental internal fixation systems that may be used include titanium plate or rod systems (i.e., SUMMITT™,
EAGLE PLATE™, REFLEX PLATE™, and ATLANTIS PLATE™).
4. INDICATIONS
C-VBR is a vertebral body replacement device indicated for use in the cervical spine (spanning C2-T1 vertebral
bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or
osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord
and neural tissues in cervical degenerative disorders. The C- VBR System is intended to be used with supplemental
fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprising cancellous and/or
corticocancellous bone graft, as an adjunct to fusion. Graft material may be packed into the C-VBR from the
superior, inferior and anterior windows. Densely packed graft material inside the C-VBR will increase the
likelihood of fusion. The C-VBR System is also intended to restore the integrity of the spinal column even in the
absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in
whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the
surgeon’s discretion.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
Fax (502) 245-5768.
www.cardinalspine.net
Lxxxx Rev 00 2015-XX
5. MATERIAL
C-VBR is made from titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F136 Standard Specification for
Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications
(UNS R56401).
6. CONTRAINDICATIONS
C-VBR is contraindicated in the presence of localized infection, active systemic infection or in cases where the
patient has demonstrated allergic or foreign body sensitivity to the implanted material.
C-VBR is contraindicated in the presence of severe osteoporosis, which may prevent adequate fixation and preclude
use of this or other implanted orthopedic devices.
Relative contraindications include osteopenia and conditions that may result in excessive stresses being placed on
the bone and implants, such as severe obesity.
Relative contraindications also include patients whose activity, lifestyle, occupation, mental capacity or mental
illness may impede compliance with post-operative restrictions and precautions during healing and thus increase the
risk of implant failure.
In the presence of relative contraindications, the physician should weigh the relative risks and benefits when
deciding whether a patient is a suitable candidate for these devices.
7. WARNINGS
Supplemental Fixation. When used in the cervical spine at one or two levels, the C-VBR System is intended to be
used with supplemental fixation cleared by the FDA for use in the cervical spine. When three or more corpectomies
are performed during the decompression, supplemental fixation should include posterior fixation which is cleared by
the FDA. The physician may also want to consider the use of FDA cleared posterior supplemental fixation in oneand two-level corpectomy cases when relative contraindications are present.
Size Selection. Proper implant size selection is important for achieving satisfactory anterior and middle column
support. Implant height mismatch may lead to poor clinical outcomes. Undersized implants may migrate into and
damage neural and/or vascular structures. Oversized implants may distort the normal anatomical relationships
(stretch the posterior facets). Oversized implants may result in neural stretch injuries, accelerated implant failure,
implant subsidence, implant expulsion, or fracture of an adjacent vertebral body.
During the implantation of the C-VBR distraction of the cervical spine must be limited to no more than 3 mm
relative to the original length from the superior end-plate of the cephalad vertebral body to the inferior end-plate of
the caudad vertebral body as determined by pre-operative radiography, Computerized Tomography (CT) and
Magnetic Resonance Imaging (MRI) measurements. Limiting the amount of distraction will reduce the probability
of neural stretch injuries, device subsidence, and adjacent vertebral body fracture. We discourage using any
maneuver that actively distracts the cervical spine. Manual traction applied to the skull or Caspar pin distraction of
the vertebral bodies during the surgical dissection or implantation of the device should be avoided.
Breakage. Implants function to maintain alignment and load-share with adjacent bone until normal healing occurs.
If healing is delayed or does not occur, metal fatigue can lead to breakage of the implant. Factors influencing the
longevity of the implant include the degree of union, loads produced by weight bearing, and activity levels.
Damage. Bending of the implant, notches or scratches resulting from improper preoperative handling or
mishandling during surgery can weaken the implant and lead to premature failure. Always use care when inserting
the implant and ensure that retraction of adjacent bone is adequate to enable proper placement without the need to
use excessive force.
Dissimilar Metals. Internal fixation devices which come into contact with metal objects must be made from like or
compatible materials. All implanted metals and alloys are subject to uniform corrosion occurring at a slow and
acceptable rate. However, dissimilar metals in contact result in an acceleration of this process which can ultimately
result in fatigue fracture of the implants. Do not use dissimilar metals together, such as titanium and stainless steel.
8. PRECAUTIONS
Single-Use Only. Never use a device that has been subjected to stresses or other inappropriate handling, even
though external appearance may be unchanged. Microscopic defects and internal stress patterns may have occurred
and could lead to early breakage. Under no circumstances should an explanted device ever be reimplanted.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
Fax (502) 245-5768.
www.cardinalspine.net
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Removal of Supplemental Fixation. The surgeon should carefully weigh the relative risks versus benefits of
removing supplemental fixation once fusion has been achieved. Prolonged implantation of the supplemental fixation
may introduce several risks including corrosion and local tissue reactions, bending, loosening, breakage (with
attendant risk of migration, pain, discomfort or neurovascular injury), increased susceptibility to infection, and bone
loss due to stress shielding. When elected, implant removal should be followed by adequate post-operative care. In
some cases, such as diminished life expectancy, the risks of surgery and post-operative complications may outweigh
the benefit of removal.
Patient Instruction. The patient must be made aware of the limitations of internal fixation devices and the need for
compliance with post-operative restrictions during the healing phase. The patient should be advised that excessive
demands could lead to loosening, bending, breakage or migration of the implant. Implant failure may require
corrective surgery. Implant migration may result in injury to the spinal cord, trachea and esophagus or to other
neurovascular structures in the neck. Implant migration and failure may also result in non-union of the bone graft
with the host bone.
Fatigue Testing, Device Performance and Patient Selection. Based on fatigue testing results, when using C-VBR,
the physician/surgeon should consider the levels of implantation, patient weight, patient activity level, other patient
conditions, etc., which may impact on the performance of this system.
C-VBR components should not be used with components of any other VBR system or manufacturer.
9. POTENTIAL COMPLICATIONS AND ADVERSE EFFECTS
Complications arising from specific use of C-VBR (and complications that may arise from the use of supplemental
fixation devices in general) include the following:
General risks attendant with surgery including those risks related to general anesthesia
Bending, fracture, or loosening of the device component (implant)
Sensitivity to the implant material
Allergic foreign body reaction
Early or late infection
Diminished bone density due to stress shielding
Loss of fixation of the implant and/or the supplemental internal fixation
Delayed fusion or non-union
Pain, discomfort, or abnormal sensations due to the presence of the device
Nerve injury due to surgical trauma or the presence or migration of the device
Neurological difficulties including paraplegia, quadriplegia, radicular pain, tethering of nerves in scar tissue,
muscle weakness, paresthesia, and persistent pain
Vascular injury that could result in catastrophic bleeding
Malpositioned implants or implant migration that could result in erosion of adjacent arteries or veins long after
the initial postoperative period
Dural tears during the implantation procedure that could require further surgery for repair, chronic cerebrospinal
fluid leak or fistula, and possible meningitis
Visceral injury due to the implantation procedure, breakage of the device and/or loss of fixation
Bursitis
Paralysis
Death
Spinal cord impingement or damage
Vertebral fracture
Fracture of other bony structures
Reflex sympathetic dystrophy
Degenerative changes or instability in segments adjacent to fused vertebral levels
Local osteolysis in articulating joints
Pseudoarthrosis
Mechanical grinding and generation of wear debris
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
Fax (502) 245-5768.
www.cardinalspine.net
Lxxxx Rev 00 2015-XX
10. PRE-SURGERY PREPARATION
C-VBR and instruments are supplied NON-STERILE, and must be sterilized before use (See Sections 14 -15).
11. IMPLANTATION AND REMOVAL TECHNIQUE
Surgical Preparation. After satisfactory induction of general anesthesia, the patient should be positioned supine on
the operating table. Ample padding should be used to cushion pressure points. The spine should be placed in a
neutral position. Administration of prophylactic antibiotics and cleansing of the skin surrounding the surgical site
should be performed prior to the draping of the sterile surgical field.
Exposure. Anterior-posterior and/or lateral radiographs should be used to identify the operative level and determine
placement of the starting incision. The intended surgical level should be directly visualized and confirmed
radiographically. Self-retaining and/or hand held retractors should be used to protect the internal organs and
neurovascular structures when possible. Caspar pins should be used only to assist with exposure and soft tissue
retraction. Distraction across the corpectomy channel via the Caspar system should be avoided.
Site Preparation. All pathologic material (disk, bone, tumor, and/or cartilage) should be removed and discarded.
The dissection should continue until healthy subchondral bone is exposed. Excessive removal of healthy
subchondral bone should be avoided as it may lead to implant subsidence and segmental instability. Healthy bone
from the channel corpectomy may be recovered and used as autograft inside an implant.
Implant Geometry. Proper orientation of C-VBR is achieved by observation of landmarks. The superior and
inferior ends of the device are open with the four sidewalls forming a trapezoidal footprint. When implanted, the
device is oriented such that the larger base of the trapezoid is anterior. Further confirmation of proper orientation is
achieved by noting that each of the posterior and lateral faces of the device incorporates parallel and axially aligned
rows of fenestrations.
Safety Features. The trapezoidal shape of C-VBR in the axial, sagittal and coronal planes deter over-insertion
intraoperatively and posterior migration thereafter. The trapezoidal shape, anterior spikes, and the lateral “brakes”
are designed to improve patient safety during and after surgery.
!
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A
B
C
Safety features of C-VBR: (A) The trapezoidal footprint of C-VBR with anterior spikes as seen from above. (B) The
anterior spikes, lateral brakes and trapezoidal shape in the sagittal plane seen from the side; and (C) The anterior
spikes and lateral brakes when looking at the front of the device.
Sizes and Features.
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www.cardinalspine.net
Lxxxx Rev 00 2015-XX
C-VBR implants with parallel endplates have no endplate angulation. They are provided with in two anteriorposterior width footprints:
• Anterior width of 12 mm, posterior width of 11 mm, depth (anterior-posterior) of 10 mm, and heights ranging
from 16 mm to 72 mm;
• Anterior width of 14 mm, posterior width of 13 mm, depth (anterior-posterior) of 12 mm, and heights ranging
from 16 mm to 72 mm.
C-VBR implants with lordotic endplates have endplate angulation (lordosis). They are provided with two anteriorposterior footprints:
• Anterior width of 12 mm, posterior width of 11 mm, depth (anterior-posterior) of 10 mm, and heights ranging
from 18 mm to 39 mm;
• Anterior width of 14 mm, posterior width of 13 mm, depth (anterior-posterior) of 12 mm, and heights ranging
from 18 mm to 39 mm.
See Section 13 for additional details.
No assembly required.
C-VBRs are single-piece devices manufactured using electrical discharge machining. There are no components to
assemble or disassemble.
Implant Selection. Prepare the bony endplates by removal of the cartilage and exposure of bleeding subchondral
bone. C-VBR is designed to maximize the potential contact area between graft and host bone. Therefore, meticulous
removal of the cartilaginous end-plates will optimize probability of subsequent fusion. A caliper may be used to
determine width, depth, and length (height). Software on most Computerized Tomography (CT) and Magnetic
Resonance Imaging (MRI) programs will allow for pre-operative planning to estimate C-VBR height and spinal
lordosis.
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A
B
The above CT scan images show a pathologic fracture due to metastatic lung cancer to the C6 vertebral body. The
patient presented with pain and myelopathy. Software “tools” estimated the approximate distance from C5 to C7 to
be 17 mm (A). The CT software determined the Cobb angle to have approximately 12 degrees of cervical kyphosis
(B). These estimates may change when the patient is positioned under anesthesia.
The Cardinal Spine sizer instruments may also be used to determine the proper implant width and depth (footprint).
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www.cardinalspine.net
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In the example above, the Cardinal Spine sizing instrument is used to determine the correct implant size (width and
depth or footprint) to be used.
Choose the longest device that will fit into the surgically created cavity. If necessary, up to 1.5 millimeters of the
endplate spikes may be trimmed from either side of the C-VBR to reduce implant height. When vertebral end-plates
are parallel, the C-VBR with parallel endplates may be the best option. When vertebral end-plates are divergent or
the surgeon desires to restore lordosis, the C-VBR with lordosis may provide a better option. Once the proper length
is achieved, proceed to Implant Placement.
The C-VBR and C-VBR Lordotic should approximate the superior and inferior endplates of the corpectomy trough.
Safety tip: Cardinal Spine does not recommend the use of skeletal traction during surgical site preparation or device
implantation. Intra-operative spinal elongation increases the post-operative axial loading stress at the bone-implant
interface. Excessive bone-implant stress increases the likelihood of post-operative subsidence, implant expulsion,
and adjacent level vertebral body fracture. Intra-operative traction also increases the probability of a stretch injury
to the nerves and should therefore be avoided.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
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www.cardinalspine.net
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Implant Placement. C-VBR allows for graft material to be placed into the device either before or after
implantation. For safety reasons, we recommend placement of graft material into the implant prior to placement into
the surgically created cavity. Packing of graft material through the superior, inferior, and anterior windows should
improve the consistency and density of the graft within the device and eliminate “air gaps.” Additional bone graft
may be placed through the anterior windows of the device after implantation. The addition of bone graft anterior to
the device and posterior to a cervical plate may assist with post-operative radiographic determination of fusion (the
“sentinel sign”). Overly aggressive bone impaction, after device implantation, may result in implant migration and
spinal cord injury. If too much resistance is encountered during implant placement the surgeon should re-evaluate
the dimensions of the corpectomy channel and/or consider using a smaller size C-VBR.
!
A
B
C
C-VBR filled with autologous bone graft harvested from the corpectomy channel (A). C-VBR in the grasp of a
needle driver (B). C-VBR visualized within the corpectomy trough (C).
Once the device is filled with bone graft, the surgeon may grasp one of the anterior corners of the device with a
hemostat, needle driver, or similar grasping instrument. A generic bone impaction device can be used to nudge the
device into the desired position. The successful placement of the device should be verified on anterior-posterior and
lateral radiographs. The device should be centrally located with respect to the anterior-posterior axis of the column
of vertebral bodies. The device should be located in the anterior to middle column of the vertebral bodies with
respect to the lateral axis of the patient.
Safety tip: Pack the C-VBR on the back table with as much graft as possible.
Visual and radiographic confirmation of the desired cage position is recommended.
Supplemental Fixation. An anterior plate or posterior instrumentation indicated for use in the cervical spine (see
Section 2) is to be affixed to the vertebral bodies above and below the interspace to ensure adequate support until
bony fusion is achieved. The magnitude of supplemental fixation added is at the discretion of the surgeon.
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Radiographic confirmation of C-VBR and supplemental fixation position.
Wound Closure. Consider use of a drain such as a Jackson-Pratt and place as necessary. Closure is performed using
conventional technique.
Removal / Revision. Exposure is gained using the same technique as for the original implantation. Borders of the
implant may be verified directly, fluoroscopically or radiographically. The borders of the implant may then be
detached from the surrounding tissues with the use of a knife (soft tissue), osteotome or high speed drill (bone). The
implant may then be grasped with a hemostat, a Kocher or similar instrument for removal.
Revision involves the removal of the implant followed by the insertion of an implant of larger height, larger
footprint or both. The use of FDA cleared anterior cervical supplemental fixation and/or FDA cleared posterior
cervical supplemental fixation is strongly encouraged for revision cases.
12. USE IN MR ENVIRONMENT
C-VBR has not been evaluated for safety and compatibility in the MR environment. It has not been tested for
heating, migration, or image artifact in the MR environment. The safety of C-VBR in the MR environment is
unknown. Scanning a patient who has this device may result in patient injury.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
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www.cardinalspine.net
Lxxxx Rev 00 2015-XX
13. HOW PROVIDED
C-VBR is provided in the following sizes:
Anterior width,
mm
Posterior width,
mm
Anterior-posterior
depth, mm
Height, mm*
Lordosis,
degrees
Parallel Endplates – No Lordosis
10
16, 17.75, 19.5, 21.25,
23, 24.75, 26.5, 28.25,
30, 33.5, 37, 44,
51, 58, 65, 72
13
12
16, 17.75, 19.5, 21.25,
23, 24.75, 26.5, 28.25,
30, 33.5, 37, 44
51, 58, 65, 72
12
11
10
18, 19.75, 21.5, 23.25,
25, 26.75, 28.5, 30.25,
32, 35.5, 39
11.5
14
13
12
18, 19.75, 21.5, 23.25,
25, 26.75, 28.5, 30.25,
32, 35.5, 39
9.6
12
14
11
0
0
Lordotic Endplates
*Height excludes the teeth on each end of the device.
14. PACKAGING AND STORAGE
C-VBR and instruments are supplied NON-STERILE, and must be sterilized (see also Sections 15-16).
Implant packaging must be intact at the time of receipt. Implants are placed in specially designed trays or in cases,
which can be sterilized directly.
Use care in handling and storage of the implants. Improper handling can induce microscopic cracks and/or internal
stresses that can ultimately lead to fatigue fracture of the implants. Except as where described in the implantation
technique, cutting, sharply bending or scratching the surface can decrease the strength and fatigue resistance of the
implant system and should be avoided. Implants should be protected from exposure to corrosive environments such
as salt air, moisture, etc. Inspection is recommended prior to surgery to determine if damage has occurred during
storage.
15. REPROCESSING INSTRUCTIONS FOR REUSABLE NON-STERILE INSTRUMENTS
These reprocessing instructions apply to reusable non-sterile C-VBR surgical instruments supplied by Cardinal
Spine.
CAUTION: These instructions DO NOT APPLY to single-use devices.
Note: The C-VBR surgical instruments supplied by Cardinal Spine (sizer instruments) are single piece units with no
moving parts. No disassembly is required before cleaning and sterilization.
These reprocessing instructions have been validated as being capable of preparing reusable Cardinal Spine C-VBR
instruments for reuse. It is the responsibility of the reprocessor to ensure that the reprocessing is performed using
appropriate equipment, materials and personnel to achieve the desired result. This normally requires validation and
routine monitoring of the process. Any deviation by the reprocessor from these instructions should be evaluated for
effectiveness and potentially adverse consequences.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
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www.cardinalspine.net
Lxxxx Rev 00 2015-XX
WARNINGS
Follow the instructions and warnings issued by the suppliers of any cleaning and disinfection
agents or equipment used.
Highly alkaline conditions can damage products with aluminum parts.
Instruments with movable or retractable features and textured surface finishes require special
attention during cleaning.
Avoid exposure to hypochlorite solutions, as these will promote corrosion. Scratches or dents can
result in breakage.
Care should be taken to remove any debris, tissue or bone fragments that may collect on the
instrument.
Limitations on
Reprocessing
The instruments do not have an indefinite functional life.
Repeated processing has minimal effects on instrument life and function.
End of useful life is generally determined by wear or damage in surgical use.
Carefully inspect instruments between uses to verify proper functioning.
Damaged instruments should be repaired or replaced to prevent potential injury to the patient.
Reprocessing Instructions
Thoroughly clean instruments as soon as possible after use. If cleaning must be delayed,
immerse instruments in a compatible detergent solution or water to prevent drying and
encrustation of surgical soil.
Avoid prolonged exposure to saline to minimize the chance of corrosion. Remove excessive soil
with a disposable wipe.
Care at the
Point of Use
Containment and
Transportation
Reprocess instruments as soon as is reasonably possible after use.
Rinse instruments under cool tap water to remove gross soil.
Use a syringe to flush water through any crevices and hard to reach areas.
Prepare a solution of Enzol® according to manufacturer's recommendations (1 oz/gal) using
lukewarm tap water.
Immerse the instruments in the detergent and allow to soak for a minimum of one (1) minute.
Use a soft bristled brush to remove soil, paying close attention to any hard to reach areas.
Use a syringe to flush the detergent through any hard to reach areas.
Manual Cleaning
Remove the instruments from the detergent and rinse using reverse osmosis/deionized (RO/DI)
water for a minimum of one (1) minute.
Visually inspect each item for any visible soil.
If any soil is present, repeat the manual cleaning process.
Dry the instruments with a clean soft cloth and filtered pressurized air.
Reassemble the inserter instrument by screwing the outer shaft onto the inner shaft.
Cleaning Inspection
Inspect all instruments before sterilization or storage to ensure the complete removal of soil from
surfaces.
If soil is still present, repeat the manual cleaning process.
Inspection and
Functional Testing
Visually inspect the instrument and check for damage and wear.
Moveable parts should have smooth movement without excessive play.
Disinfection
Instruments must be terminally sterilized prior to surgical use.
See STERILIZATION PROCEDURES section below.
Information
Requests
To request any additional information, please contact Cardinal Spine at the number shown below.
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
Fax (502) 245-5768.
www.cardinalspine.net
Lxxxx Rev 00 2015-XX
16. STERILIZATION PROCEDURES
C-VBR is supplied clean and non-sterile and must be sterilized prior to use. Steam sterilize following AAMI
standards and a validated cycle to achieve a sterility assurance level (SAL) of 10-6.
Implants must be removed from their packaging and sterilized prior to use.
Do not stack trays containing implants or instruments.
For C-VBR implants, Cardinal Spine recommends individual packaging in a sterilization pouch that is FDA-cleared
for the following sterilization cycle:
prevacuum cycle, exposure at 270 °F (132 °C) for 4 minutes, followed by 20 minutes drying time.
For C-VBR implants provided in a kit (set), either with or without C-VBR instruments, Cardinal Spine recommends
2 layers of an FDA-cleared wrap that is cleared for the following cycle:
prevacuum cycle, exposure at 270 °F (132 °C) for 4 minutes, followed by 30 minutes drying time.
For C-VBR instruments alone, Cardinal Spine recommends 2 layers of an FDA-cleared wrap that is cleared for the
following cycle:
prevacuum cycle, exposure at 270 °F (132 °C) for 4 minutes, followed by 30 minutes drying time.
Cardinal Spine, LLC
12307 Old LaGrange Road, Suite 105
Louisville, KY 40245
Phone (502) 777-4788
Fax (502) 245-5768
www.cardinalspine.net
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Cardinal Spine 12307 Old LaGrange Road, Suite 105, Louisville, KY 40245 Phone (502) 777-4788.
Fax (502) 245-5768.
www.cardinalspine.net
Lxxxx Rev 00 2015-XX