Medtronic 7771023 Instructions for Use

Elevate™ Spinal System M708348B559E Rev. D

2020-10-13

IMPORTANT INFORMATION ON THE ELEVATE™ SPINAL 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 who has been instructed as to its mechanical and material applications and
limitations.

DESCRIPTION

The Elevate™ Spinal System is an expandable PEEK, tantalum, and titanium alloy interbody device consisting of various
lengths and starting heights, which can be inserted between two lumbar or lumbosacral vertebral bodies to give support and
correction during lumbar interbody fusion surgeries. The Elevate™ Spinal System expands for adjustable lordosis and height to
match patient anatomy. 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. Implants may be implanted via a posterior or transforaminal approach and the procedure may be open or minimally
invasive. The Elevate™ Spinal System can be implanted unilaterally and bilaterally. The Elevate™ Spinal System is intended to
be inserted with Elevate™ Spinal System reusable instruments.

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

INDICATIONS

The Elevate™ Spinal System Expandable Interbody Fusion Device is indicated for interbody fusion 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 in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. 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. These patients should be
skeletally mature and have had six months of non-operative treatment. Implants may be implanted via an open or a minimally
invasive posterior approach. Implants are 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 devices are intended
to be used with supplemental fixation instrumentation, cleared by the FDA for use in the lumbar spine.

CONTRAINDICATIONS

This device is not intended for cervical spine use.
Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ Any other condition which would preclude the potential benefit of spinal implant surgery, such as the presence of tumors or

congenital abnormalities, fracture local to the operating site, elevation of sedimentation rate unexplained by other diseases,
elevation of white blood count (WBC), or a marked left shift in the WBC differential count.

▪ Suspected or documented allergy or intolerance to composite materials.
▪ Any case not needing a fusion.
▪ Any case not described in the Indications.
▪ Any patient unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem should not be considered for this type of

surgery.

▪ These devices must not be used for pediatric cases, nor where the patient still has general skeletal growth.
▪ Spondylolisthesis unable to be reduced to Grade 1.
▪ Any case where implant selected would be too large or too small to achieve a successful result.

▪ Any case that requires the mixing of metals from two different components or systems.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant use would interfere with anatomical structures or expected physiological performance.
▪ Prior fusion at the level to be treated.

Note: although not absolute contraindications, conditions to be considered as potential factors for not using this device include:

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

Consideration that the segmental stability can be affected by a variety of factors.

POTENTIAL ADVERSE EVENTS

Adverse effects may occur when the device is used either with or without associated instrumentation.
Risk of adverse effects as a result of movement and non-stabilization may increase in cases where associated complementary

support is not employed. Potential adverse events include:

▪ Implant migration.
▪ Breakage of device.
▪ Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
▪ Pressure on the surrounding tissues or organs.
▪ Loss of proper spinal curvature, correction, height, and/or reduction.
▪ Infection.
▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis).
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and/or development of pain.
▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, or other types of

serious injury and Cerebral spinal fluid leakage.

▪ Hemorrhage of blood vessels and/or hematomas.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Deep venous thrombosis, thrombophlebitis, and/or pulmonary embolus.
▪ Bone graft donor site complication.
▪ Inability to resume activities of normal daily living.
▪ Early or late loosening or movement of device.
▪ Urinary retention, loss of bladder control, or other types of urological system compromise.
▪ Scar formation possibly causing neurological compromise or compression around nerves and/or pain.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and/or

vertebral body) and/or bone graft or bone graft harvest site at, above, and/or below the level of surgery.

▪ Retropulsed graft.
▪ Herniated nucleus pulposus, disc disruption or degeneration at, above, or below the level of surgery.
▪ Loss of or increase in spinal mobility or function.
▪ Reproductive system compromise including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g., pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of potential growth of the operated portion of the spine.
▪ Death.

Note: additional surgery might become necessary to correct adverse effects.

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. Use of this product 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 or in cases
that do not develop a union will not be successful.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and correct selection and
placement of implants are important considerations in successful use of the system. Further, the proper selection and the
compliance of the patient will greatly affect results. Trial distractors enable a simple and safe size destination. Over-distraction is
to be avoided. Patients who smoke were shown to have a reduced incidence of bone fusion. These patients should be advised
of this fact and warned of this consequence. Obese, malnourished, and/or alcohol/drug abuse patients and those with poor
muscle and bone quality and/or nerve paralysis are also poor candidates for spinal fusion.

When used in deformity procedures, undersizing the implant may limit endplate engagement and potentially lead to implant
migration and/or expulsion.

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

Document the used implants per patient with REF and LOT, so the tracking, which is required by law, is guaranteed. Implants
are only for single use. Do not re-process or re-use devices labeled as single use devices. Re-processing or re-use of single