Medtronic 4240086 Instructions for Use

Anatomic PEEK™ Cervical Fusion

M708348B066E Rev. C

System

2020-04-06

IMPORTANT INFORMATION ON THE ANATOMIC PEEK™ CERVICAL INTERBODY
FUSION SYSTEM

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 from medical grade polyetherether- ketone (PEEK) with tantalum markers and is provided sterile.

DESCRIPTION

The Anatomic PEEK™ Cervical Fusion System consists of cages of various widths and heights which can be inserted between
two cervical vertebral bodies to give support and correction during cervical 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. Anatomic PEEK devices must be
used with supplemental fixation.

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

Medical grade tantalum, medical grade CP Ti, and medical grade PEEK may be used together. Never use titanium or titanium
alloy implants with stainless steel in the same construct.

INDICATIONS

The Anatomic PEEK Cervical Fusion System is indicated for cervical interbody fusion pro- cedures 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. This device is to be used in patients
who have had six weeks of non-operative treat- ment. The Anatomic PEEK device is to be used with supplemental fixation. The
Anatomic PEEK Cervical Fusion System is also required to be used 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, and is to be
implanted via an open anterior approach.

CONTRAINDICATIONS

The Anatomic PEEK™ device is not intended for posterior surgical implantation. Contraindications include:

▪ 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 theWBC 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 and/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.
▪ This device must not be used for pediatric cases.
▪ Patients with a known hereditary or required bone friability or calcification problem should not be considered for this type of

surgery.

▪ Prior fusion at the level to be treated.

▪ Any patient in which implant use 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 adverse events or complications associated with spinal fusion surgery without instrumentation are possible. With
instrumentation, a listing of possible adverse events or complications includes:

▪ 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.

▪ Loss of spinal mobility or function.
▪ 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 components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of components.
▪ Implant migration.
▪ Foreign body (allergic) reaction to 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.

▪ Ileus, gastritis, bowel obstruction or other types of 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 or 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/or 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

This system was designed for single patient use only. Do not reuse or reprocess this product. Reuse and reprocessing 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.

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 and/or allograft bone graft comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft
bone with bone marrow aspirate may not be successful. No spinal implant can withstand body loads without the support of
bone. In this event, bending, loosening, disas- sembly, 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.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without
a previous spinal surgery.

This system should not be used in any case not described in the indications.
Further proper selection and compliance of the patient greatly affect results. Patients who smoke were 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.