Medtronic 3491210 Instructions for Use

Perimeter™ Interbody Fusion Device M708348B767E Rev. B

2020-10-08

IMPORTANT INFORMATION ON THE PERIMETER™ INTERBODY FUSION DEVICE

PURPOSE

This device is a fusion device intended for stabilization and to promote bone fusion during the normal healing process following
surgical correction of disorders of the spine. 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 manufactured in medical grade polyetheretherketon (PEEK) or titanium alloy (titanium-6aluminum-4vanadium ELI).
This interbody device is provided sterile or non-sterile. Refer to the package label for sterility information.

DESCRIPTION

The Perimeter™ Interbody Fusion Device consists of cages of various widths and heights which can be inserted between two
lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow
geometry of the implants allows them to be packed with autogenous bone and/or allograft bone graft comprised of cancellous

and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate.The Perimeter
Device is to be used with supplemental fixation instrumentation.

The device is offered in titanium alloy (titanium-6aluminum-4vanadium ELI) or PEEK. This interbody device is offered sterile or
non-sterile. Refer to the package label for implant sterility information.

The Perimeter
length, and between 19mm and 38mm in width. An array of lordosis options are provided for this device spanning from 4° to 15°
of angulation. Both the PEEK and Titanium Alloy (Titanium-6Aluminum-4Vanadium ELI) devices are designed with teeth across
both the superior and inferior surfaces to allow the implant to grip the superior and inferior end plates, thus providing expulsion
resistance. Additionally, the titanium alloy version of this device offers lateral windows for visibility of the autogenous bone
and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with
bone marrow aspirate.

Based on fatigue testing results, when using the Perimeter™ Interbody Fusion Device, the physician/surgeon should consider
levels of implantation, patient weight, patient activity level, other patient conditions, etc., which may impact performance of this
system.

Never use stainless steel and titanium implant components in the same construct.
Medical grade titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy may be used together. Never

use titanium, titanium alloy, and/or medical grade cobalt-chromium-molybdenum alloy with stainless steel in the same construct.
PEEK implants may be used with stainless steel, titanium, or cobalt-chromium-molybdenum alloy implants.

No warranties, express or implied, are made. Implied warranties of merchantability and fitness for a particular purpose or use
are specifically excluded.

™

Interbody Fusion Device is offered in a variety of sizes ranging from 8mm to 20mm in height, 15mm to 28mm in

™

Interbody

INDICATIONS

The Perimeter™ Interbody Fusion Device is indicated for interbody fusion with autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate in
patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also
have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with
degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have
had six months of non-operative treatment. These implants may be implanted via a variety of open or minimally invasive
approaches. These approaches include anterior, lateral, and oblique. These devices are intended to be used with supplemental
fixation instrumentation, which has been cleared for use in the lumbar spine.

CONTRAINDICATIONS

This device is not intended for cervical spine use.
Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.

▪ Pregnancy.
▪ Mental illness.
▪ Any condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or

congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases,
elevation of white blood count (WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented allergy or intolerance to composite materials.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem.
▪ Pediatric cases, nor where the patient still has general skeletal growth.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Cases requiring mixing metals from two different components or systems.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.

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

Adverse events may occur when the device is used either with or without associated instrumentation.
Risk of adverse events as a result of movement and non-stabilization may increase in cases where associated complementary

support is not employed. Potential adverse events include:

▪ Implant migration.
▪ Breakage of device.
▪ Foreign body reaction to implants including possible tumor formation, auto immune disease, and/or scarring.
▪ Pressure on the surrounding tissues or organs.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of

serious injury.

▪ Cerebral spinal fluid leakage.
▪ Haemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Bone graft donor site complication.
▪ Inability to resume activities of normal daily living.
▪ Early or late loosening or movement of device.
▪ Urinary retention,loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or

vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.)
▪ Change in mental status.
▪ Death.

WARNINGS AND PRECAUTIONS

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 without autogenous bone and/or allograft bone graft
comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow aspirate or
in cases that do not develop a union will not be successful.