Medtronic G7743511 Instructions for Use

DIVERGENCE™ Anterior Cervical Fusion System

2014-08-25

AUSTRALIAN SPONSOR:
Medtronic Australasia Pty Ltd

97 Waterloo Rd
North Ryde, NSW 2113
Australia

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (in U.S.A)
Telephone: [phone] (Outside U.S.A)
Fax: [phone]

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

M708348B382E Rev. A

IMPORTANT INFORMATION ON THE DIVERGENCE™ ANTERIOR CERVICAL FUSION SYSTEM

PURPOSE

The DIVERGENCE™ Anterior Cervical Fusion System consists of temporary implants (plates and bone screws) intended for anterior screw fixation, and
fusion devices (interbody cages) intended to stabilize and 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 who has
been instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The DIVERGENCE™ Anterior Cervical Fusion System consists of plates, bone screws, and interbody cages.
The DIVERGENCE™ anterior cervical plates and bone screws are available in a broad range of size offerings that are intended for anterior screw fixation

intended for stabilization use during the normal healing process following surgical correction of disorders of the spine. Fixation is provided by bone screws
inserted into the vertebral body of the cervical spine using an anterior approach. The DIVERGENCE™ anterior cervical plate and bone screws are made

from titanium alloy and are provided sterile.
The DIVERGENCE™ anterior cervical cages are available in various widths and heights that 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 graft
and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and must be used with supplemental fixation. The cages are
manufactured from medical grade Polyetheretherketone (PEEK) with titanium alloy wire markers and are provided sterile.

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

construct.

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

INDICATIONS

The DIVERGENCE™ anterior cervical plate and bone screw components are intended for anterior interbody screw fixation from C2-T1. The indications and
contraindications of spinal instrumentation systems should be well understood by the surgeon. The plate and bone screw components are indicated for use
in the temporary stabilization of the anterior spine during the development of spinal fusions in patients with: 1) degenerative disc disease (as defined by
neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); 2) trauma (including fractures); 3) tumors;

4) deformity (defined as kyphosis, lordosis, or scoliosis); 5) pseudoarthrosis; and/or 6) failed previous fusions.
The DIVERGENCE™ anterior cervical cage component 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. 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 cage is to be used in patients who have had six weeks of non-operative treatment. The

DIVERGENCE™ cage must be used with supplemental fixation. The DIVERGENCE™ cage is also required to be used with autogenous bone graft and/or
allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is to be implanted via an open, anterior approach.

When used together, the DIVERGENCE™ components can be used only to treat cervical disc disease.

CONTRAINDICATIONS

The DIVERGENCE™ Anterior Cervical Fusion System 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 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.
▪ Any case not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ For interbody cage, patients with known hereditary or required bone friability or calcification problems.
▪ For interbody cage, prior fusion at the level to be treated.
▪ Infection local to the operative site and/or signs of local inflammation.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.

▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Suspected or documented allergy or intolerance to the component materials.
▪ 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.
NOTA BENE: This device system is intended for anterior cervical intervertebral body fusions only.
Although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

▪ Severe bone resorption.
▪ Osteomalacia.
▪ Severe osteoporosis.

WARNING: This plate device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ 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.
▪ Disc disruption or degeneration at, above, or below the level of surgery.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of the components and implant migration.
▪ For interbody cage, cauda equina syndrome.
▪ For plate device, atelectasis, ileus, gastritis.
▪ For plate device, dysphagia.
▪ For plate device, pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing skin

penetration, irritation, and/or pain.

▪ For plate device, bursitis.
▪ 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, wound necrosis, wound dehiscence, damage to

blood vessels, or cardiovascular system compromise.

▪ Herniated nucleus pulposus, and/or retropulsed graft.
▪ Gastrointestinal and/or reproductive system compromise including sterility and loss of consortium.
▪ Infection.
▪ Loss of bowel and/or bladder control or other types of urological system compromise.
▪ Loss of neurological 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.

▪ Loss of spinal mobility or function and inability to perform the activities of daily living.
▪ Interference with roentgenographic, CT, and/or MR imaging because of the presence of the implants.
▪ Neuropathy, neurological deficits (transient or permanent), bilateral paraplegia, reflex deficits, arachnoiditis, and/or muscle loss.
▪ 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 interbody cage device into vertebral body(ies).
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of implants or instruments.
▪ Wound necrosis or wound dehiscence.

Note: Additional surgery may be necessary to correct some of these anticipated adverse events.

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.

The DIVERGENCE™ Anterior Cervical Fusion System plate and bone screw components are only temporary implants used for the correction and
stabilization of the spine. This system is also intended to be used to augment the development of a spinal fusion by providing temporary stabilization. This
device system is not intended to be the sole means of spinal support. Bone grafting must be part of the spinal fusion procedure in which the

DIVERGENCE™ Anterior Cervical Fusion System is utilized. Use of a plate device without bone graft material may not be successful.
Use of the DIVERGENCE™ Anterior Cervical Fusion System cage component 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, 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.