PEEK PREVAIL® Cervical Interbody
0381384E Rev. B
Device
2016-03-18
IMPORTANT INFORMATION ON THE PEEK PREVAIL® CERVICAL INTERBODY
DEVICE
PURPOSE
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally
mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. This system is indicated for
single-level use only in the C2-T1 anterior spine.
DESCRIPTION
The PEEK PREVAIL® Cervical Interbody Device is an intervertebral body fusion device with internal screw fixation. The screws
protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant.
The implant is “I-Beam” shaped with a 2 screw midline configuration. This device is intended to be radiolucent and the interior
space of the product is to be used with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or
corticocancellous bone graft.
The PEEK PREVAIL
radiopaque markers and a Nitinol screw locking mechanism. The screws used with this device (ZEPHIR
Screws) are manufactured from titanium alloy.
Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.
Based on fatigue testing results, when using the PEEK PREVAIL
consider the levels of implantation, patient weight, patient activity level, other patient conditions,etc., which may impact the
performance of this system. Patients with previous spinal surgery at the level(s) to be treated may have different clinical
outcomes compared to those without a previous surgery.
®
Cervical Interbody device implant is manufactured from PEEK Optima LT1® and contains tantalum
®
Cervical Interbody device, the physician/surgeon should
®
Anterior Cervical
INDICATIONS
The PEEK PREVAIL® Cervical Interbody Device is indicated for anterior cervical interbody fusion procedures in skeletally
mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined
as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates
producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. The PEEK PREVAIL
Cervical Interbody Device must be used with internal screw fixation provided by ZEPHIR® Anterior Cervical Screws. The PEEK
PREVAIL
of cancellous and/or corticocancellous bone graft and implanted via an open, anterior approach. This cervical device is to be
used in patients who have had six weeks of non-operative treatment.
®
Cervical Interbody Device implants are to be used with autogenous bone graft and/or allogenic bone graft comprised
®
CONTRAINDICATIONS
The PEEK PREVAIL® Cervical Interbody device is not intended for posterior surgical implantation. Contraindications include,
but are not limited to:
▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.
▪ Any medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the presence
of tumors or congenital abnormalities, elevation of sedimentation rate unexplained by other diseases, elevation of white
blood count (WBC), or a marked left shift in the WBC differential count.
▪ Any patient having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone
quality, or anatomical definition.
▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Fever or leukocytosis.
▪ Infection local to the operative site.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this
condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.
▪ Signs of local inflammation.
▪ Suspected or documented metal allergy or intolerance.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
Contraindications of this device are consistent with those of other spinal systems.
POTENTIAL ADVERSE EVENTS
All of the possible adverse events or complications associated with spinal fusion surgery without instrumentation are possible.
With instrumentation, a listing of possible adverse events or complications includes, but is not limited to:
▪ Bone loss or decrease in bone density, possibly caused by stress shielding.
▪ Cauda equina syndrome, neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits,
arachnoiditis, and/or muscle loss.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Loss of spinal mobility or function and inability to perform the activities of daily living.
▪ Change in mental status.
▪ Death.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of the components and implant migration.
▪ Foreign body (allergic) reaction to the implants, debris, corrosion products, including metallosis, staining, tumor formation,
and/or autoimmune disease.
▪ Fracture, microfracture, resorption, damage, penetration, and/or retropulsion of any spinal bone of the autograft, or at the
bone graft harvest site at, above, and/or below the level of surgery.
▪ Gastrointestinal complications.
▪ Graft donor site complications including pain, fracture, infection, or wound healing problems.
▪ Hemorrhage, hematoma, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis, damage to blood
vessels, or cardiovascular system compromise.
▪ Wound necrosis or wound dehiscence.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Infection.
▪ Loss of neurologial function, including paralysis (complete or incomplete), dysesthesia, hyperesthesia, anesthesia,
paraesthesia, appearance of radiculopathy, and/or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.
▪ Non-union (or pseudarthrosis), delayed union, and mal-union.
▪ Postoperative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Scar formation possibly causing neurological compromise around nerves and/or pain.
▪ Subsidence of the device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
Note: additional surgery may be necessary to correct some of these anticipated adverse events.
WARNINGS
A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other
patient conditions may compromise the results. The PEEK PREVAIL
ZEPHIR
bone graft comprised of cancellous and/or corticocancellous bone graft may not be successful. No spinal implant can withstand
body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage of the device(s) will
eventually occur.
Preoperative and operating procedures including knowledge of surgical techniques, proper selection and placement of the
implant, and good reduction are important considerations in the success of surgery.
Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may
have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of
the instrumentation.
Further, the proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown
to have an increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence.
Obese, malnourished, and/or alcohol abuse patients are also poor candidates for spine fusion.
An implanted device should never be re-used unless otherwise specified. Implants which have come in contact with the patient
are designed for single patient use only. Do not reuse, reprocess, or re-sterilize used implants. Reuse, reprocessing, or resterilization may compromise the structural integrity of these implants and create a risk of contamination of the implants which
®
Anterior Cervical Screws to augment stability. Use of this product without autogenous bone graft and/or allogenic
®
Cervical Interbody Device must be used with the
could result in patient injury, illness, or death. Unused Implants that have not been in contact with the patient or the patient’s
blood may be re-sterilized and used in subsequent procedures.
PRECAUTIONS
Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information given in this document should be conveyed to the patient.
For US audiences only
Caution: federal law (USA) restricts these devices to sale by or on the order of a physician.
MRI INFORMATION
MR Conditional
The PEEK PREVAIL
comparison to previously evaluated Medtronic products. A patient with this device can be safely scanned immediately after
device placement under the following conditions:
Static Magnetic Field
®
Cervical Interbody Device was determined to be MR-Conditional based on non-clinical testing and
▪ Static magnetic field of 1.5 Tesla and 3 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under Normal Operating Mode, for 15
minutes of scanning per pulse sequence.
MRI-Related Heating
In non-clinical testing, the PEEK PREVAIL
(Magnetic Resonance Imaging) performed for 15 minutes of scanning (i.e., per pulse sequence) in 1.5 Tesla/64 MHz
(Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded,
horizontal field scanner) and 3 Tesla/128 MHz (Excite, Software 14X.M5, General Electric Healthcare, Milwaukee, WI. Activeshielded, horizontal field scanner) MR systems:
®
Cervical Interbody Device produced the following temperature rises during an MRI
1.5 Tesla 3 Tesla
MR system reported, whole body average SAR 2.9 W/kg 2.9 W/kg
Calormetry Measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change 1.5˚C1.9˚C
Artifact Information
MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the PEEK
PREVAIL
device may be necessary.
MRI Patient Counseling Information
Physicians should communicate with the patient the following information about MRI with respect to the PEEK PREVAIL
Cervical Interbody Device:
▪ PEEK PREVAIL
®
Cervical Interbody Device. Therefore, optimization of MR imaging parameters to compensate for the presence of this
®
Cervical Interbody Device performance has been established for MRI systems at field strengths of 1.5
Tesla and 3.0 Tesla.
®
▪ During an MRI, the patient may notice a warming sensation around the implant or feel a tingling sensation. If the warming or
tingling sensation is uncomfortable, the patient should communicate this to the MR technologist, the MRI should be
stopped, and the settings adjusted to reduce or eliminate the sensation. The highest temperature change observed in nonclinical testing was +1.9ºC (associated with specific conditions previously listed).
▪ Additionally, the metal in the implant may cause the MRI image to be distorted in the area around the implant. The MRI can
be adjusted to minimize the image distortion.
Physicians should instruct patients to:
▪ Inform any healthcare personnel (e.g. doctor or MR technologist) that an implanted interbody device exists prior to receiving
an MRI.
▪ The patient’s doctor will recommend whether or not an MRI is appropriate.
If PEEK PREVAIL
advised that this combination has not been tested in the MR environment and, therefore, higher heating and possible injury to
the patient may occur.
®
Cervical Interbody Device is used in connection with any device which is not MR Conditional, please be
IMPLANT SELECTION
The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
Plastic polymer implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to
the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and
postoperative management to minimize stresses on the implant, such stresses may cause material fatigue and consequent
breakage, bending, or loosening of the device before the healing process is complete, which may result in further injury or the
need to remove the device prematurely.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the aforementioned contraindications should be
avoided.
▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or
damaged. Implants and instruments should be protected during storage especially from corrosive environments.
▪ Further information on the use of this system will be made available on request.
▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the
equipment and should personally assemble the devices to verify all parts and necessary instruments are present before the
surgery begins.
▪ The type of construct to be assembled for the case should be determined prior to beginning the surgery. An adequate
inventory of implant sizes should be available at the time of surgery, including sizes larger and smaller than those expected
to be used.
▪ Unless sterile packaged, all parts should be cleaned and sterilized before use. Additional sterile components should be
available in case of an unexpected need.
INTRAOPERATIVE
▪ The instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss
of neurological functions.
▪ Breakage, slippage, or misuse of instruments or implant components may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the instrumentation, autogenous bone graft and/or allogenic bone
graft comprised of cancellous and/or corticocancellous bone graft should be used. Autogenous bone graft and/or allogenic
bone graft comprised of cancellous and/or corticocancellous bone graft must be placed in the area to be fused and graft
material must extend from the upper to the lower vertebrae being fused.
▪ Bone cement should not be used since this material will make removal of the components difficult or impossible. The heat
generated from the curing process may also cause neurologic damage and bone necrosis.
POSTOPERATIVE
The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.
▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight bearing is
recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the
device are complications which can occur as a result of excessive weight bearing or muscular activity. The risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting
devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
▪ To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical
vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and
restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be
advised not to smoke or consume excess alcohol during the bone healing process.
▪ Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this
permanent physical restriction in body motion.
▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the
mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device. It is important that
immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if
the components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury
occurs.
▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.
PACKAGING
Packages for each of the components should be intact upon receipt. If a loaner or consignment system is used, all sets should
be carefully checked for completeness and all components, including instruments, should be carefully checked to ensure there
is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.
CLEANING
Disassembly instructions and detailed cleaning instructions can be found at http://manuals.medtronic.com/. Refer to the
“Reprocessing Instructions for the PEEK PREVAIL
sterilization instructions specific to the threaded outer inserter (1220777), threaded inserter shaft (1220222), screw guide head
(1225555), and screw guide shaft (1204477).
®
Inserter and Screw Guide” – M708348B117 for disassembly, cleaning, and
STERILIZATION
The contents of the implant package for the PEEK PREVAIL® Cervical Interbody Device are provided sterile via gamma
irradiation. The ZEPHIR
are provided non-sterile.
®
Anterior Cervical Screws and instruments used with the PEEK PREVAIL® Cervical Interbody Device
Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened
sterile package provided by the company, all implants and instruments used in surgery must be sterilized by the hospital prior to
use. Remove all packaging materials prior to sterilization. Only sterile products should be placed in the operative field. Unless
specified elsewhere, these products are recommended to be steam sterilized by the hospital using one of the following sets of
process parameters:
Table 1: Sterilization cycle parameters for the US and its territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
MINIMUM DRY TIME
1
Steam Gravity Displacement 250°F (121°C) 30 Minutes 30 Minutes
Steam Gravity Displacement 270°F (132°C) 15 Minutes 30 Minutes
Steam Gravity Displacement 275°F (135°C) 10 Minutes 30 Minutes
Steam Dynamic-Air-Removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 275°F (135°C) 3 Minutes 16 Minutes
Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment. It is the end user’s responsibility to use only sterilizers and
accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization
cassettes) that have been cleared by the Food and Drug Administration (FDA) for the selected sterilization cycle specifications
(time and temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization
cycles.
For medical facilities located outside the US and its territories: some non-US health care authorities recommend sterilization
according to these parameters to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.
Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
MINIMUM DRY TIME
1
Steam Gravity Displacement 273°F (134°C) 20 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-Air-Removal 273°F (134°C) 20 Minutes 30 Minutes
1
The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient
atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.
Note: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The
sterilization parameters listed in Tables 1 and 2 can be achieved in both health care facility and larger, industrial sterilizer
models. Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment.
Sterilization instructions can be found at http://manuals.medtronic.com/. Refer to the “Reprocessing Instructions for the PEEK
PREVAIL
®
Inserter and Screw Guide” – M708348B117 for disassembly, cleaning, and sterilization instructions specific to the
threaded inserter outer (1220777), threaded inserter shaft (1220222), screw guide head (1225555), and screw guide shaft
(1204477).
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
FURTHER INFORMATION
Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.
©2016 Medtronic Sofamor Danek USA, Inc. All rights reserved.
AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd
97 Waterloo Rd
North Ryde, NSW 2113
Australia
EXPLANATION OF SYMBOLS
Authorized representative in the European Community
CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.
Do not re-use
Use-by date
Batch code
Catalogue number
Non-sterile
For US audiences only
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, TN 38132
Telephone: 800 933 2635 (USA)
901 396 3133 (Outside USA)
Fax: 901 396 0356
Medtronic B.V.
Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00
Manufacturer
The device complies with European Directive MDD
93/42/EEC
Sterilized using irradiation
MR Conditional
Consult instructions for use
Loading...