Medtronic G6620247 Instructions for Use

Divergence™ Anterior Cervical

M708348B381E Rev. B

Fusion System (For Stand-Alone
Interbody Device Only)

2020-10-19

IMPORTANT INFORMATION ON THE DIVERGENCE™ ANTERIOR CERVICAL FUSION
SYSTEM (FOR STAND-ALONE INTERBODY DEVICE ONLY)

PURPOSE

The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody fusion device with internal screw
fixation. The Divergence™ Anterior Cervical Fusion System is indicated for anterior cervical interbody fusion procedures in
skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1. This system is indicated for single-level
use only in the C2-T1 anterior spine.

DESCRIPTION

The Divergence™ Anterior Cervical Fusion System is an intervertebral body fusion device with internal screw fixation. The
system is comprised of an interbody cage and bone screws.

The Divergence™Anterior Cervical Fusion System anterior cervical cages are provided in 0 and 6° of lordosis, 5-12mm heights,
15-20mm widths and 12-16mm depths. This device is intended to be radiolucent, and the interior space of the product is 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. The Divergence™ stand-alone cervical interbody device is
manufactured from medical grade polyetheretherketone (PEEK) and contains radiopaque markers made from medical grade
titanium alloy. The PEEK interbody cage also comes preassembled with a titanium alloy, built-in rotary locking mechanism.

Bone screws used with this device are provided in self-drilling and self-tapping options and are manufactured from medical
grade titanium alloy. Bone screws are provided in 3.5mm and 4.0mm diameters and 9-17mm lengths.

The PEEK material used conforms to ASTM F2026 and the titanium alloy material used conforms to ASTM F136.
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 stainless steel and

titanium implant components in the same construct.
To achieve best results, do not use Divergence™ Anterior Cervical Fusion System implant components with components from

any other system or manufacturer unless specifically allowed to do so in this or another Medtronic document. As with all
orthopaedic and neurosurgical implants, none of the Divergence™ Anterior Cervical Fusion System components should ever be
reused under any circumstances.

INDICATIONS

The Divergence™ Anterior Cervical Fusion System consists of a stand-alone interbody device indicated for use in anterior
cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from C2-C3 to C7-T1.
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. The Divergence™ Anterior Cervical Fusion System must be used with internal screw fixation. The Divergence™
Anterior Cervical Fusion System is also required to be used with 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. This cervical device is to be This cervical device is to be used in patients who have
had 6 weeks of non-operative treatment. Patients with previous non-fusion spinal surgery at involved level may be treated with
the device.

CONTRAINDICATIONS

The Divergence™ Anterior Cervical Fusion System is not intended for posterior surgical implantation.
Contraindications include:

▪ Any case needing to mix metals from different components.
▪ Any case not described in the indications.

▪ 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.

▪ Patients having inadequate tissue coverage over the operative site or where there is inadequate bone stock, bone quality,

or anatomical definition.

▪ Patients unwilling to cooperate with postoperative instructions.
▪ Conditions not described in the indications.
▪ Fever or leukocytosis.
▪ Infection local to the operative site.
▪ Mental illness.
▪ Morbid obesity.
▪ Pregnancy.
▪ Prior fusion at the level(s) to be treated.
▪ Rapid joint disease, bone absorption, osteopenia, and/or osteoporosis. Osteoporosis is a relative contraindication since this

condition may limit the degree of obtainable correction and/or the amount of mechanical fixation.

▪ Signs of local inflammation.
▪ Suspected or documented metal allergy or intolerance.
▪ 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.

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.

▪ 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 components.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Early or late loosening of components and 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.

▪ 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 development or continuation of pain, numbness, neuroma, tingling
sensation, sensory loss, and/or spasms.

▪ 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 device into vertebral bodies.
▪ 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 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 results. Patients with previous spinal surgery at the levels to be treated may have different
clinical outcomes compared to those without a previous spinal surgery. The Divergence™ Anterior Cervical Fusion System must
be used along with the provided bone screws to augment stability. 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 support of bone. In this event, bending, loosening, disassembly, and/or breakage of devices will eventually occur.