Medtronic X0312076 Instructions for Use

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.

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C distractor/inserter (P/N 875777) and the associated spreader blocks (P/Ns 875791, 875793, 875794,

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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.

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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