PERIMETER® C (Titanium) Spinal
M708348B431E Rev. B
System
2016-04-07
IMPORTANT INFORMATION ON THE PERIMETER® C (TITANIUM) SPINAL SYSTEM
PURPOSE
This device is a fusion device intended for stabilization use and to promote bone fusion during the normal healing process
following surgical correction of spinal disorders. The product should be implanted only by a physician thoroughly knowledgeable
in the implant's material and surgical aspects and instructed as to its mechanical and material applications and limitations. This
device is offered in titanium alloy (titanium-6aluminium-4vanadium ELI). This interbody device is provided in sterile or non-sterile
(titanium alloy) forms. Refer to the package label for sterility information.
DESCRIPTION
The PERIMETER® C (Titanium) Spinal System consists of spacers of various widths and heights which can be inserted
between two cervical vertebral bodies to give support and correction during cervical interbody fusion procedures. Additionally,
this implant has six degrees of lordosis and the superior and inferior surfaces of the implant are designed with teeth which
interact with the surface of the vertebral endplates to aid in resisting expulsion. The hollow geometry of the implants allows them
to be packed with autogenous bone graft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone
graft and is to be used with supplemental fixation in all procedures. The PERIMETER
instrumentation that enables the surgeon to implant the devices via an open, anterior approach.
No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.
Medical grade titanium implants and medical grade PEEK implants may be used together. Never use titanium or titanium alloy
implants with stainless steel in the same construct.
Note: the CATALYST
and 875795) used with this inserter do not mate with part numbers X0312081 to X0312085 or X1214542 to X1214546, and
therefore, should not be used to implant these devices.
®
C distractor/inserter (P/N 875777) and the associated spreader blocks (P/Ns 875791, 875793, 875794,
®
C (Titanium) Spinal System is used with
INDICATIONS
The PERIMETER® C Spinal System is intended to be used 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 who have had six weeks of non-operative
treatment. 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. Additionally, the PERIMETER
and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation and
implanted via an open, anterior approach.
®
C Spinal System implants are to be used with autogenous bone graft
CONTRAINDICATIONS
The PERIMETER® C Spinal System 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 or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Any case not requiring fusion.
▪ Suspected or documented allergy or intolerance to the component materials.
▪ Pediatric cases or where the patient still has general skeletal growth.
▪ Patients with a known hereditary or required bone friability or calcification problem.
▪ Prior fusion at the level to be treated.
▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any case that requires the mixing of metals from two different components or systems.
Nota bene: although not absolute contraindications, conditions to be considered as potential factors for not using this device
include:
▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.
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, or muscle loss.
▪ Cessation of any potential growth of the operated portion of the spine, loss of spinal mobility or function, or 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, or breakage of any or all of the components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, or meningitis.
▪ Early or late loosening of the components or implant migration.
▪ Foreign body (allergic) reaction to the implants, debris, or corrosion products. Reactions include metallosis, staining, tumor
formation, or autoimmune disease.
▪ Fracture, microfracture, resorption, damage, penetration, or retropulsion of any spinal bone, or autograft at the bone graft
harvest site at, above, 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. This also includes 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, or the development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, or spasms.
▪ Non-union (or pseudarthrosis), delayed union, or mal-union.
▪ Postoperative change in spinal curvature, loss of correction, height, or reduction.
▪ Scar formation possibly causing neurological compromise around nerves or pain.
▪ Subsidence of the device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, 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 AND PRECAUTIONS
Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of single use devices may
compromise the structural integrity of the device and/or create a risk of contamination of the device, which could result in patient
injury, illness, or death. Do not use if package is opened or damaged or if expiration date has passed.
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. Use of this product in cervical interbody fusion procedures without autogenous
bone graft and/or allogenic 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, 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.
Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal 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 threads 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, or alcohol-abuse patients are also poor candidates for spine fusion.
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.
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.
Surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the
human anatomy. Unless great care is taken in patient selection, placement of the implant, and postoperative management to
minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage or loosening of the
device before the fusion process is complete. This may result in further injury or the need to remove the device prematurely.
Based on fatigue testing results, when using the PERIMETER
levels of implantation, patient weight, patient activity level, and other patient conditions which may impact the performance of
this system.
®
C Spinal System, the physician/surgeon should consider the
DEVICE FIXATION
Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
and designated by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not
used with devices from any other source.
PREOPERATIVE
▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions 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 supplied sterile, all implants should be sterilized before use. Additional sterile implants should be available in case of
any unexpected need.
▪ Unless supplied sterile, all instruments should be cleaned and sterilized before use.
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 must be used in cervical interbody procedures.
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, or break, the device should be revised 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
Devices are supplied in both sterile and non-sterile forms. Packages for each of the components should be intact upon receipt.
Once the seal on a sterile package has been broken, the product should not be re-sterilized. 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 AND DECONTAMINATION
Unless just removed from an unopened Medtronic sterile package, all instruments and implants must be disassembled (if
applicable) and cleaned using neutral cleaners before sterilization, before introduction into a sterile surgical field, or (if
applicable) before returning the product to Medtronic. Cleaning and disinfecting of instruments can be performed with aldehydefree solvents at higher temperatures. Cleaning and decontamination must include the use of neutral cleaners followed by a
deionized water rinse. Cleaning instructions and associated disassembly instructions (if applicable) can be found at
www.medtronic.com/manuals.
Note: certain cleaning solutions such as those containing formalin, glutaraldehyde, bleach, or other alkaline cleaners may
damage some devices, particularly instruments. These solutions should not be used unless instructed by the Instrument Care,
Cleaning and Sterilization Quick Reference Guide (part number 0381424). Also, many instruments require disassembly before
cleaning.
For detailed instructions for use specific to the instruments used with the PERIMETER
disassembly, cleaning, and sterilization instructions, refer to the following documents packaged with the instruments or available
by document number at http://manuals.Medtronic.com:
▪ “IMPORTANT INFORMATION ON THE REUSABLE INSTRUMENTS USED WITH PERIMETER
part number M708348B328.
▪ “IMPORTANT INFORMATION ON THE CATALYST
All products should be treated with care. Improper use or handling may lead to damage or improper functioning of the device.
®
C REUSABLE INSTRUMENTS”, part number M708348B329.
®
C (Titanium) Spinal System, including
®
C SPINAL SYSTEM”,
STERILIZATION
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 Medtronic, all implants 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
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
The sterilization cycles listed in Table 2 are not considered by the Food and Drug Administration (FDA) to be standard
sterilization cycles. 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) cleared by the FDA for the selected
sterilization cycle specifications (time and temperature).
Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories
METHOD CYCLE TEMPERATURE EXPOSURE TIME
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
MINIMUM DRY TIME
MINIMUM DRY TIME
1
1
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.
PRODUCT COMPLAINTS
To report product problems, contact Medtronic.
MRI INFORMATION
The PERIMETER® C (Titanium) Spinal System has not been evaluated for safety, heating, migration, or compatibility in the
magnetic resonance (MR) environment. It has not been tested for heating, migration, or image artifact in the MR environment.
The safety of PERIMETER
device may result in patient injury.
®
C (Titanium) Spinal System in the MR environment is unknown. Scanning a patient who has this
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
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
For US audiences only
Manufacturer
Sterilized using irradiation
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
Consult instructions for use
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