Medtronic 3600201 Instructions for Use

Infinity™ OCT System M708348B572E Rev. C

2021-04-14

IMPORTANT INFORMATION ON THE INFINITY™ OCT SYSTEM

PURPOSE

The Infinity™ Occipitocervical-Upper Thoracic System (OCT System) is intended to help provide immobilization and stabilization
of spinal segments as an adjunct to fusion of the craniocervical, cervical, and/or upper thoracic spine (occiput-T3).

DESCRIPTION

The Infinity™ OCT System is a posterior occipitocervical-upper thoracic system, which consists of a variety of shapes and sizes
of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a
variety of configurations, with each construct being tailor-made for the individual case.

The Infinity™ OCT System is fabricated from medical grade titanium alloy and medical grade cobalt chromium. Medical grade
titanium alloy and medical grade cobalt chromium may be used together. Never use titanium alloy and/or cobalt chromium with
stainless steel in the same construct. No warranties, expressed or implied, are made. Implied warranties of merchantability and
fitness for a particular purpose or use are specifically excluded.

To achieve best results, do not use any of the Infinity™ OCT System implant components with components from any other
system or manufacturer unless specifically labeled to do so in this or another Medtronic document. As with all orthopedic and
neurosurgical implants, Infinity™ OCT System components should never be reused under any circumstances.

INDICATIONS

The Infinity™ OCT System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for
the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the thoracic spine
from T1-T3:

▪ Traumatic spinal fractures and/or traumatic dislocations.
▪ Instability or deformity.
▪ Failed previous fusions (e.g. pseudarthrosis).
▪ Tumors involving the cervical spine.
▪ Degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as

confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Infinity™ OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a
limited time in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient
duration to permit achievement of fusion.

The Infinity™ OCT System may be used with PASS OCT Patient Specific UNiD OCT rods. In order to achieve additional levels
of fixation, the Infinity™ OCT System may be connected to the CD Horizon™ Spinal System and Vertex™ Reconstruction
System rods with the Infinity™ OCT System rod connectors. Transition rods with differing diameters may also be used to
connect the Infinity™ OCT System to the CD Horizon™ Spinal System. Refer to the CD Horizon™ Spinal System package
insert, Vertex™ Reconstruction System and PASS OCT Spinal System package insert for a list of the indications of use.

Note: The 3.0mm multi axial screw (MAS) requires the use of MAS CROSSLINK™ at each level in which the 3.0mm screw is
intended to be used.

The lateral offset connectors and MAS extension connectors are intended to be used with 3.5mm and larger diameter multi axial
screws. The lateral offset connectors and MAS extension connectors are not intended to be used with 3.0mm screws.

Note: Segmental fixation is recommended for these constructs.

CONTRAINDICATIONS

Contraindications include:

▪ Active infectious process or significant risk of infection (immunocompromise).
▪ Signs of local inflammation.
▪ Fever or leukocytosis.
▪ Morbid obesity.
▪ Pregnancy.
▪ Mental illness.

▪ Grossly distorted anatomy caused by congenital abnormalities.
▪ Any other medical or surgical condition which would preclude the potential benefit of spinal implant surgery, such as the

presence of congenital abnormalities, 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 metal allergy or intolerance.
▪ Any case not needing a bone graft and fusion.
▪ Any case where the implant components selected for use would be too large or too small to achieve a successful result.
▪ Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
▪ Any patient in which implant utilization would interfere with anatomical structures or expected physiological performance.
▪ Any patient unwilling to follow postoperative instructions.
▪ Any case not described in the indications.

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

All of the adverse events associated with spinal fusion surgery without instrumentation are possible. With instrumentation, a
listing of potential adverse events includes:

▪ Early or late loosening of any or all of the components.
▪ Disassembly, bending, and/or breakage of any or all of the components.
▪ Foreign body (allergic) reaction to implants, debris, corrosion products (from crevice, fretting, and/or general corrosion),

including metallosis, staining, tumor formation, and/or autoimmune disease.

▪ Pressure on the skin from component parts in patients with inadequate tissue coverage over the implant possibly causing

skin penetration, irritation, fibrosis, necrosis, and/or pain.

▪ Bursitis.
▪ Tissue or nerve damage caused by improper positioning and placement of implants.
▪ Post-operative change in spinal curvature, loss of correction, height, and/or reduction.
▪ Infection.
▪ Dural tears, pseudomeningocele, fistula, persistent CSF leakage, and/or meningitis.
▪ Loss of neurological function (e.g. sensory and/or motor), including paralysis (complete or incomplete), dysesthesias,

hyperesthesia, anesthesia, paresthesia, appearance of radiculopathy, and/or the development or continuation of pain,
numbness, neuroma, spasms, sensory loss, tingling sensation, and/or visual deficits.

▪ Neuropathy, neurological deficits (transient or permanent), paraplegia, paraparesis, reflex deficits, irritation, arachnoiditis,

and/or muscle loss.

▪ Urinary retention or 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.
▪ Non-union (pseudarthrosis), delayed union, or mal-union.
▪ Loss of or increase in spinal mobility or function.
▪ Inability to perform the activities of daily living.
▪ Bone loss or decrease in bone density, possibly caused by stresses shielding.
▪ Graft donor site complications including pain, fracture, or wound healing problems.
▪ Ileus, gastritis, bowel obstruction or loss of bowel control, or other types of gastrointestinal system compromise.
▪ Reproductive system compromise, including sterility, loss of consortium, and sexual dysfunction.
▪ Development of respiratory problems (e.g. pulmonary embolism, atelectasis, bronchitis, pneumonia, etc.).
▪ Hemorrhage, hematoma, occlusion, seroma, edema, hypertension, embolism, stroke, excessive bleeding, phlebitis, wound

necrosis, wound dehiscence, damage to blood vessels, or other types of cardiovascular system compromise.

▪ Change in mental status.
▪ Death.

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

WARNINGS AND PRECAUTIONS

A successful result is not always achieved in every surgical case. This fact is especially true in spinal surgery where many
extenuating circumstances may compromise the results. This device system is not intended to be the sole means of spinal
support. Use of this product without a bone graft or in cases that develop into a non-union will not be successful. No spinal
implant can withstand body loads without the support of bone. In this event, bending, loosening, disassembly, and/or breakage
of the device will eventually occur.