Medtronic 2968001 Instructions for Use

Adaptix™ Interbody System with

M333023W072E Rev. B

Titan nanoLOCK™ Surface
Technology

2020-09-15

IMPORTANT INFORMATION ON THE ADAPTIX™ INTERBODY SYSTEM WITH TITAN
NANOLOCK™ SURFACE TECHNOLOGY

Note: not all parts may be available in each geography.

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 instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consists of additive manufactured titanium cages
of various lengths and heights to accommodate patient anatomy. These devices can be inserted between two lumbar or
lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The open geometry of the
implants allows them to be packed with autograft bone graft and/or allogenic bone graft comprised of cancellous and/or
corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The interbody device is treated with
Titan Surface Technologies™, where nanoLOCK™ Surface Technology (MMN™) is designed to improve fixation to the
adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic-roughened surface with nano-scale
features. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental
fixation systems cleared for use in the lumbar spine.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic
implants, in no case may the implants be re-used.

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

INDICATIONS

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures
for patients diagnosed with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2 to S1. 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. The Adaptix™ Interbody System with Titan
nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody
System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic 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 an open or a minimally invasive posterior approach and/or transforaminal approach.

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 the implant components selected for use 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.

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

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

POTENTIAL ADVERSE EVENTS

Adverse effects may occur when the device is used either with or without associated instrumentation. The 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 the device(s).
▪ 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.

▪ 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 the device(s).
▪ 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 and/or retropulsion 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.

▪ 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 any potential growth of the operated portion of the spine.
▪ Death.

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. Use of this product without bone graft 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 the successful use of the system. Further, proper selection and
compliance of the patient will greatly affect results. 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.