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.

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.

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 thread will reduce the stability of
the instrumentation. Further, proper selection and compliance of the patient will 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. Patients with poor
muscle and bone quality and/or nerve paralysis are also not good candidates for spine fusion.

A device that has been implanted should never be reused or reprocessed under any circumstances. Implants which have come
in contact with the patient are designed for single patient use only. Reuse and reprocessing may compromise the structural
integrity of these implants and create a risk of contamination of implants which could result in patient injury, illness, or death.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.

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

For US audiences only

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

IMPLANT SELECTION

Selection of proper size, shape, and design of the implant for each patient is crucial to the success of the procedure. Surgical
implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to the size and
shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and postoperative
management to minimize stresses on the implant, such stresses may cause material fatigue and consequent breakage,
bending, or loosening of the device before the healing process is complete, which may result in further injury or the need to
remove the device prematurely.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be used when handling and storing implants. Implants should not be scratched or damaged. Implants and

instruments should be protected during storage especially from corrosive environments.

▪ Since mechanical parts are involved, the surgeon should be familiar with the various components and should personally

assemble the devices to verify all parts and necessary instruments are present.

▪ The type of construct to be assembled for the case should be determined prior to surgery. An adequate inventory of implant

sizes should be available at the time of surgery, including sizes larger and smaller than those expected to be used.

▪ These devices are provided sterile. Additional sterile components should be available in case of an unexpected need.

MRI INFORMATION

MR Conditional

The Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) was determined to be MR
Conditional based on non-clinical testing and engineering rationales. A patient with this device can be safely scanned
immediately after device placement under the following conditions:

▪ Static magnetic field of 1.5 Tesla and 3.0 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm (30 T/m) or less.
▪ Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under normal operating mode for 15

minutes of scanning per pulse sequence.

Under the scan conditions defined above, a worst-case cervical plate system representative of the Divergence™ Anterior
Cervical Fusion System (For Stand-Alone Interbody Device Only) produced the following temperature rises during MRI
performed for 15 min of scanning (i.e. per pulse sequence) in 1.5 Tesla/64 MHz MR system (Magnetom, Siemens Medical
Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3.0
Tesla/128 MHz (Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:

In non-clinical testing, a worst-case interbody device representative of the Divergence™ Anterior Cervical Fusion System
(stand-alone interbody device only) produced the following temperature rises during MRI performed for 15 min of scanning (i.e.
per pulse sequence) in 1.5 Tesla/64 MHz MR system (Magnetom, Siemens Medical Solutions, Malvern, PA. Software
Numaris/4, Version Syngo MR 2002B DHHS Active-shielded, horizontal field scanner) and 3.0 Tesla/128 MHz (Excite, HDx,
Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR systems:

1.5 Tesla 3.0 Tesla

MR system reported, whole body averaged SAR 2.9 W/kg 2.9 W/kg
Calorimetry measured values, whole body averaged SAR 2.1 W/kg 2.7 W/kg
Highest temperature change +1.8˚C+1.7˚C

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the
Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only. Therefore, optimization of MR imaging
parameters to compensate for the presence of these devices may be necessary.

If the Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only) is used in connection with any
device which is not MR Conditional, be advised this combination has not been tested in the MR environment and, therefore,
higher heating and possible injury to the patient may occur.

INTRAOPERATIVE

▪ Instructions in any available applicable surgical technique manual should be carefully followed.
▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to nerves will cause loss of

neurological functions.

▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the instrumentation autogenous bone and/or allograft bone graft

comprised of cancellous and/or corticocancellous bone graft, and/or demineralized allograft bone with bone marrow
aspirate should be used. The graft material must be placed in the area to be fused and it must extend from the upper
vertebrae to the lower vertebrae being fused.

▪ Bone cement should not be used since this material will make removal of components difficult or impossible. Heat

generated from the curing process may also cause neurologic damage and bone necrosis.

POSTOPERATIVE

The physician's postoperative directions and warnings to the patient and the corresponding patient compliance are extremely
important.

▪ Detailed instructions on use and limitations of the device should be given to the patient. If partial weight bearing is

recommended or required prior to firm bony union, the patient must be warned that bending, loosening, or breakage of the
device are complications which can occur as a result of excessive weight bearing or muscular activity. Risk of bending,
loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the
patient is active, debilitated, demented, or otherwise unable to use weight supporting devices. The patient should be
warned to avoid falls or sudden jolts in spinal position.

▪ To allow maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical

vibrations that may loosen the device construct. The patient should be warned of this possibility and instructed to limit and
restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient should be
advised not to smoke or consume excess alcohol during the bone healing process.

▪ Patients should be advised of their inability to bend at the point of spinal fusion and taught to compensate for this

permanent physical restriction in body motion.

▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the

mechanism of fatigue, these stresses can cause eventual bending, loosening, or breakage of the device. It is important
immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if
components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury
occurs.

▪ Retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

PACKAGING

Devices are supplied sterile. Packages for devices should be intact upon receipt. Once the seal on the sterile package is
broken, the product should not be re-sterilized. Damaged packages or products should not be used, and should be returned to
Medtronic.

STERILIZATION

These implants are supplied sterile.

PRODUCT COMPLAINTS

To report any product problems, contact Medtronic.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

©2020 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Medtronic B.V.

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

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Do not re-use

Batch code

Manufacturer

Catalogue number

Non-sterile

For US audiences only

This device complies with applicable European Union
regulations and directives.

Sterilized using irradiation

Use-by date

Consult instructions for use at this website.