Medtronic 2150018 Instructions for Use

Divergence-L™ Anterior/Oblique

M708348B466E Rev. E

Lumbar Fusion System

2020-10-09

IMPORTANT INFORMATION ON THE DIVERGENCE-L™ ANTERIOR/OBLIQUE
LUMBAR FUSION SYSTEM

PURPOSE

The Divergence-L™ Anterior/Oblique Lumbar 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 instructed as to its mechanical and material
applications and limitations. The Divergence-L™ Anterior/Oblique Lumbar Fusion System 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 or Infuse™ Bone Graft (as designated below with the Divergence-L™ Anterior/Oblique Lumbar Fusion
System interbody cages) to facilitate fusion.

DESCRIPTION

The Divergence-L™ Anterior/Oblique Lumbar Fusion System consists of plates, bone screws, and interbody cages. The
Divergence-L™ Anterior/Oblique Lumbar Fusion System plates and bone screws are available in a broad range of sizes
intended for anterior screw fixation and stabilization 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 lumbar spine using an anterior or
oblique approach. The Divergence-L™ Anterior/Oblique Lumbar Fusion System plate and bone screws are manufactured from
titanium alloy and are provided sterile. Additionally, the Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody
cages may be used as supplemental fixation when used in conjunction with posterior fixation devices to treat deformity
conditions in the thoracic and lumbar spine. 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 or Infuse™ Bone Graft (as designated). Cages are manufactured from medical grade
polyetheretherketone (PEEK) and titanium alloy with tantalum 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-L™ Anterior/Oblique Lumbar Fusion System Interbody cage is intended for interbody fusion in skeletally mature
patients and is to be used with supplemental fixation instrumentation cleared for use in the lumbar spine. The Divergence-L™
Anterior/Oblique Lumbar Fusion System Interbody device is indicated for use in patients with degenerative disc disease (DDD)
at one or two contiguous levels from L2 to S1 (except as defined for use with Infuse™ Bone Graft above). 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. Additionally, the Divergence-L™ Anterior/Oblique
Lumbar Fusion System device is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These
patients should have had six months of non- operative treatment. The Divergence-L™ Anterior/Oblique Lumbar Fusion System
interbody device is intended 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-L™ Anterior/
Oblique Lumbar Fusion System interbody cage 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.
These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior
and oblique.

Divergence-L™ Anterior/Oblique Lumbar Fusion System plate and bone screw components are indicated as a supplemental
fixation device for the lumbosacral level, anterior below the bifurcation (L5-S1) of the vascular structures or anterior oblique
above the bifurcation (L1-L5) of the vascular structures. The indications and contraindications of spinal instrumentation systems
should be well understood by the surgeon. Plate and bone screw components are indicated for use in the temporary
stabilization of the anterior lumbar spine during the development of spinal fusions in patients with: 1) DDD defined by back 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; and/or 5) pseudarthrosis.

Certain sizes of the Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device may also be used with Infuse™
Bone Graft for patients diagnosed with DDD. The device may be implanted at a single level using an Anterior Lumbar Interbody
Fusion (ALIF) approach from L2-S1. The device may also be implanted at a single level using an Oblique Lateral Interbody
Fusion (OLIF) approach from L5 to S1. The Divergence-L™ Anterior/Oblique Lumbar Fusion System interbody device is
intended for use with supplemental fixation instrumentation, which was cleared for use in the lumbar spine when used to treat
DDD. Consult the labeling for the Infuse™ Bone Graft/Medtronic Interbody Fusion Device for additional information on the
specific sizes of the Divergence-L™ Anterior/Oblique Lumbar Fusion System Interbody device approved for use with Infuse™
Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with Infuse™
Bone Graft. Divergence-L Anterior/Oblique Lumbar Fusion System interbody device may also be used with Infuse™ Bone Graft.

CONTRAINDICATIONS

The Divergence-L™ Anterior/Oblique Lumbar Fusion System is not intended for posterior surgical implantation.
Contraindications include:

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

▪ 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.
▪ Cases not needing a bone graft and fusion or where fracture healing is not required.
▪ Any time implant use would interfere with anatomical structures or expected physiological performance.
▪ Fever or leukocytosis.
▪ For interbody cage, patients with known hereditary or acquired 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 component materials.
▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.

Nota bene: this device system is intended for Anterior/Oblique Lumbar intervertebral body fusions only when used to treat DDD.
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 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.
▪ Cessation of 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.
▪ 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 components and implant migration.
▪ For interbody cage, cauda equina syndrome.
▪ For plate device, atelectasis, ileus, gastritis.
▪ 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.