Medtronic 6069073 Instructions for Use

Catalyft™ PL Expandable Interbody

M333023W048E Rev. A

System

2021-05-26

IMPORTANT INFORMATION ON THE CATALYFT™ PL EXPANDABLE INTERBODY
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 instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The Catalyft™ PL Expandable Interbody System is an expandable titanium alloy interbody device consisting of interbodies of
various widths, lengths, heights, and lordotic angles 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. Implants
have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of
cancellous and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

Device lifetime for the Catalyft™ PL Expandable Interbody System is one year in which the device is expected to achieve its
performance (e.g. immobilization and stabilization as an adjunct to fusion) and maintain its safety until fusion occurs. After
fusion, the device is further designed and tested to survive the life of the patient.

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

INDICATIONS

The Catalyft™ PL Expandable Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature
patients with degenerative disc disease (DDD - defined by discogenic back pain with degeneration of the disc confirmed by
patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may
also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. Additionally, the Catalyft™ PL Expandable
Interbody System can be used with patients diagnose with spinal deformities as an adjunct to fusion. These patients should be
skeletally mature and have undergone 6 months of non-operative treatment prior to surgery. Implants are used to facilitate
fusion in the lumbar spine using autogenous bone graft and/or allograft bone graft comprised of cancellous and/or
corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate. These implants are intended for use
with supplemental internal fixation systems.

CONTRAINDICATIONS

The Catalyft™ PL Expandable Interbody System is not intended for cervical or thoracic spine use. Contraindications include:

▪ Infection local to the operative site.
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.
▪ 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.
▪ Cases not needing a fusion.
▪ Cases not described in the indications.
▪ Patients unwilling to cooperate with postoperative instructions.
▪ Patients with a known hereditary or acquired bone friability or calcification problem
▪ 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.

▪ Cases where implant components selected for use would be too large or too small to achieve a successful result.
▪ Cases requiring the mixing of metals from two different components or systems.
▪ Patients having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Patients 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.

Take into 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. 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.

▪ 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 any 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 graft and/or allogenic bone graft
comprised of cancellous and/or corticocancellous bone 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.

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 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 use