Medtronic 4031622 Instructions for Use

Capstone Control™ Spinal System M708348B120E Rev. D

2020-10-14

IMPORTANT INFORMATION ON THE CAPSTONE CONTROL™ 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 Capstone Control™ Spinal System consists of PEEK cages of various widths and heights, which can be inserted between
two vertebral bodies to give support and correction during 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.

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

INDICATIONS

The Capstone Control™ Spinal System is intended to be used in spinal fusion procedures for patients diagnosed with
Degenerative Disc Disease (DDD) at 1 or 2 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. When used for these indications, the Capstone Control™ Spinal System is
intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Additionally, the Capstone Control™ Spinal System can be used to provide anterior column support in patients diagnosed with
degenerative scoliosis as an adjunct to pedicle screw fixation.

These patients should be skeletally mature and have had 6 months of nonoperative treatment. The Capstone Control™ Spinal
System 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 when the subject device is used as
an adjunct to fusion. These implants may be implanted via an open or a minimally invasive posterior or transforaminal approach.

The 18mm Capstone Control™ Spinal System implant can only be implanted via a Posterior (PLIF) approach. When using the
18mm Capstone Control™ Spinal System implant, a minimum of 2 implants are required per spinal level.

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.

▪ Osteopenia and/or osteoporosis. Osteoporosis is a relative contraindication since this condition may limit the degree of

obtainable correction and/or the amount of mechanical fixation.

▪ 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 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, bone quality, or anatomic

definition.

▪ 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:

▪ Disassembly, bending, or breakage of the device.
▪ Implant migration (e.g. early or late loosening or movement of the device or devices).
▪ Pressure on the surrounding tissues or organs.
▪ Subsidence of the device into vertebral body.
▪ Infection.
▪ Foreign body reaction to the implants including possible tumor formation, autoimmune disease, and scarring.
▪ Discitis, arachnoiditis, and/or other types of inflammation.
▪ Fracture, microfracture, resorption, damage, or penetration of any spinal bone (including the sacrum, pedicles, and

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

▪ Bone fracture or stress shielding at, above, or below the level of surgery.
▪ Non-union (or pseudoarthrosis), delayed union, or mal-union.
▪ Retropulsed graft.
▪ Loss of neurological function, appearance of radiculopathy, dural tears, and development of pain, numbness, neuroma,

tingling sensation, sensory loss, and/or spasms.

▪ Neurovascular compromise including paralysis, temporary or permanent retrograde ejaculation in males, dysesthesia,

hyperesthesia, anesthesia, paresthesia, or other types of serious injury.

▪ Scar formation possibly causing neurological compromise or compression around nerves and pain.
▪ Cauda equine syndrome, neuropathy, neurological deficit (transient or permanent), paraplegia, paraparesis, reflex deficits,

arachnoiditis, and/or muscle loss.

▪ Cerebral spinal fluid leakage, pseudomemingocele, fisula, or meningitis.
▪ Tissue or nerve damage, irritation, and/or pain caused by improper positioning and placement of the implants or

instruments.

▪ Hemorrhage of blood vessels and hematomas, occlusion, seroma, edema, embolism, stroke, excessive bleeding, phlebitis,

damage to the blood vessels, or cardiovascular system compromise.

▪ Deep venous thrombosis, thrombophlebitis, and pulmonary embolus.
▪ Herniated nucleus pulposus, disc disruption, or degeneration at, above, or below the level of surgery.
▪ Bone graft donor site complication, including pain, fracture, infection, or poor wound healing.
▪ Wound necrosis or wound dehiscence.
▪ Ileus, gastritis, bowel obstruction, or other types of gastrointestinal system compromise.
▪ Bone loss or decrease in bone density possibly caused by stress shielding.
▪ Loss of proper spinal curvature, correction, height, and reduction.
▪ Loss of spinal mobility.
▪ Urinary retention or loss of bladder control or other types of urological system compromise.
▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. atelectasis, bronchitis, pneumonia, etc.).
▪ Cessation of any potential growth of the operated portion of the spine.
▪ Inability to resume activities of normal daily living.
▪ Change in mental status.
▪ Death.

Note: additional surgery may be necessary to correct some of these anticipated adverse events.

WARNINGS AND PRECAUTIONS

Do not re-use or re-process devices labeled as single use devices. Re-use or re-processing of single use devices may
compromise the structural integrity and the intended function of the device which could result in patient injury.

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

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. This device system is not intended to be the sole means of spinal support. The