Medtronic X0610003 Instructions for Use

Crescent™ Spinal System 0381444E Rev. C

2020-09-30

IMPORTANT INFORMATION ON THE CRESCENT™ 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 instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The Crescent™ Spinal System consists of PEEK cages of various widths and heights which can be inserted between two
lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. 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, transforaminal, or lateral approach and the procedure may be open or minimally invasive.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

INDICATIONS

The Crescent™ Spinal System 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 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 non­operative treatment. 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.
▪ 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 should not be considered for this type of

surgery.

▪ 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 would be too large or too small to achieve a successful result.
▪ Cases that require 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.

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 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.
▪ Haemorrhage 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, 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, 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, bronchitis, pneumonia, etc.).
▪ Change in mental status.
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Death.

WARNINGS AND PRECAUTIONS

Do not reuse or reprocess devices labeled as single use devices. Reuse or reprocessing of a single use devices may
compromise the structural integrity and the intended function of the device which could result in patient injury. 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, 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 a previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those
without a previous spinal surgery.

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.

For US Audiences Only

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

MR CONDITIONAL

The Crescent™ Spinal System 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

▪ Static magnetic field of 1.5 Tesla and 3-Tesla.