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.

Preoperative and operating procedures, including knowledge of surgical techniques, good reduction, and proper selection and
placement of the implants are important considerations in the successful utilization of the system by the surgeon. Further, the
proper selection and compliance of the patient will greatly affect the results. Patients who smoke have been shown to have an
increased incidence of non-unions. These patients should be advised of this fact and warned of this consequence. Obese,
malnourished, and/or patients who abuse alcohol are also poor candidates for spine fusion. Patients with poor muscle and bone
quality and/or nerve paralysis are also poor candidates for spine fusion.

The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant
mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability
or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1
vertebra, degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis,
kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other
conditions are unknown.

The implantation of spinal screw systems should be performed only by experienced spinal surgeons with specific training in the
use of this spinal screw system because this is a technically demanding procedure presenting a risk of serious injury to the
patient.

This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device and/or create a risk of contamination of the device, which
could result in patient injury, illness, or death.

Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early
breakage.

Pre-operative planning prior to implantation of posterior cervical lateral mass and pedicle screw spinal systems should include
review of cross-sectional imaging studies (e.g. CT and/or MRI) to evaluate the patient’s cervical anatomy including the
transverse foramen and the course of the vertebral arteries. If any findings would compromise the placement of lateral mass or
pedicle screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to
guide and/or verify device placement, as necessary.

Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning
beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and
neurologic structures in relation to the cervical pedicles at these levels.

Physician note: although the physician is the learned intermediary between the company and the patient, the important
medical information given 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.

IMPLANT SELECTION

The selection of the proper size, shape, and design of the implant for each patient is crucial to the success of the procedure.
Metallic surgical implants are subject to repeated stresses in use, and their strength is limited by the need to adapt the design to
the size and shape of human bones. Unless great care is taken in patient selection, proper placement of the implant, and
postoperative management to minimize stresses on the implant, such stresses may cause metal fatigue and consequent
breakage, bending, or loosening of the device before the healing process is complete, which may result in further injury or the
need to remove the device prematurely.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or pre-dispositions such as those addressed in the aforementioned contraindications should be

avoided.

▪ Care should be used in the handling and storage of the implant components. The implants should not be scratched or

otherwise damaged. The devices should be protected during storage, especially from corrosive environments.

▪ An adequate inventory of implants should be available at the time of surgery, normally a quantity in excess of what is

expected to be used.

▪ Since mechanical parts are involved, the surgeon should be familiar with the various components before using the

equipment and should personally assemble the devices to verify all parts and necessary instruments are present before the
surgery begins.

▪ Unless sterile packaged, all implants should be sterilized before use.

INTRAOPERATIVE

▪ Extreme caution should be used around the spinal cord and nerve roots. Damage to the nerves will cause loss of

neurological functions.

▪ Breakage, slippage, or misuse of device components may cause injury to the patient or operative personnel.
▪ Rods should not be repeatedly or excessively bent. Rods should not be reverse bent in the same location. Ensure implant

surfaces are not scratched or notched, since such deformations may reduce the functional strength of the construct. If rods
are cut to length, they should be cut to create a flat, non-sharp surface perpendicular to the midline of the rod. Cut rods
outside the operative field. Whenever possible, use pre-cut rods of the length needed.

▪ Whenever possible or necessary, use an imaging system to facilitate surgery.

▪ To insert a screw properly, drill a pilot hole corresponding to selected screw size and prepare screw site.
▪ Caution: do not overtap or use a screw that is either too long or too large. Overtapping or using an incorrectly sized screw

may cause nerve damage, hemorrhage, or other possible adverse events listed elsewhere in this package insert.

▪ Bone graft must be placed in the area to be fused and graft material must extend from the upper to the lower vertebrae

being fused.

▪ Before closing the soft tissues, all screws and set screws should be tightened firmly. Recheck the tightness of all screws

and/or set screws after finishing to ensure none loosened during the tightening of the other screws or set screws. Failure to
do so may cause loosening of the other implant components.

POSTOPERATIVE

The physician's postoperative directions and warnings to the patient, and the corresponding patient compliance, are extremely
important.

▪ Detailed instructions on the use and limitations of the device should be given to the patient. If partial weight-bearing is

recommended or required prior to firm bony union, the patient must be warned that bending, loosening, and/or breakage of
the device(s) are complications which may occur as a result of excessive or early weight-bearing or muscular activity. The
risk of bending, loosening, or breakage of a temporary internal fixation device during postoperative rehabilitation may be
increased if the patient is active, debilitated, or demented. The patient should be warned to avoid falls or sudden jolts in
spinal position.

▪ To allow the maximum chances for a successful surgical result, patients or devices should not be exposed to mechanical

vibrations or shock that may loosen the device construct. The patient should be warned of this possibility and instructed to
limit and restrict physical activities, especially lifting and twisting motions and any type of sport participation. The patient
should be advised not to smoke tobacco, use nicotine products, or consume alcohol or non-steroidal anti-inflammatory
medications such as aspirin during the bone graft healing process.

▪ Patients should be advised of their inability to bend or rotate at the point of spinal fusion and taught to compensate for this

permanent physical restriction in body motion.

▪ Failure to immobilize a delayed or non-union of bone will result in excessive and repeated stresses on the implant. By the

mechanism of fatigue, these stresses can cause the eventual bending, loosening, or breakage of the implant(s). It is
important that immobilization of the spinal surgical site be maintained until firm bony union is established and confirmed by
roentgenographic examination. If a state of non-union persists or if the components loosen, bend, and/or break, the
device(s) should be revised and/or removed immediately before serious injury occurs. The patient must be adequately
warned of these hazards and closely supervised to ensure cooperation until bony union is confirmed.

▪ As a precaution, before patients with implants receive any subsequent surgery (such as dental procedures), prophylactic

antibiotics may be considered, especially for high-risk patients.

▪ Infinity™ OCT System implants are temporary internal fixation devices. Internal fixation devices are designed to stabilize

the operative site during the normal healing process. After the spine is fused, these devices serve no functional purpose
and should be removed. While the final decision on implant removal is up to the surgeon and patient, in most patients,
removal is indicated because the implants are not intended to transfer or support forces developed during normal activities.
If the device is not removed following completion of its intended use, one or more of the following complications may occur:
(1) corrosion, with localized tissue reaction or pain; (2) migration of implant position, possibly resulting in injury; (3) risk of
additional injury from postoperative trauma; (4) bending, loosening, and breakage, which could make removal impractical or
difficult; (5) pain, discomfort, or abnormal sensations due to the presence of the device; (6) possible increased risk of
infection; (7) bone loss due to stress shielding; and (8) potential unknown and/or unexpected long term effects such as
carcinogenesis. Implant removal should be followed by adequate postoperative management to avoid fracture, re-fracture,
or other complications.

▪ Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

PACKAGING

Devices may be supplied in a sterile or non-sterile form. Packages for each of the implant components should be intact upon
receipt. Once the seal of the sterile package has been broken, the product should not be re-sterilized. If a loaner or consignment
system is used, all sets should be carefully checked for completeness, and all device components should be carefully checked
to ensure there is no damage prior to use. Damaged packages or products should not be used, and should be returned to
Medtronic.

STERILIZATION

Unless marked sterile and clearly labeled as such in an unopened sterile package provided by the company, all implants used in
surgery must be sterilized prior to use. Remove all packaging materials prior to sterilization. Only sterile products should be
placed in the operative field. Unless specified elsewhere, these products are recommended to be steam sterilized by the
hospital using one of the sets of process parameters in Table 1.

Table 1: Sterilization cycle parameters for the US and its territories

Method Cycle Temperature Exposure time

Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes

Minimum dry time

1

Note: because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization
process (e.g. temperatures, times) used for their equipment. It is the end user’s responsibility to use only sterilizers and
accessories (such as sterilization wraps, sterilization pouches, chemical indicators, biological indicators, and sterilization
cassettes) cleared by the Food and Drug Administration (FDA) for the selected sterilization cycle specifications (time and
temperature). The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.

For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these process parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease.

Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories

Method Cycle Temperature Exposure time

Steam Dynamic-air-removal 273°F (134°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 273°F (134°C) 20 Minutes 30 Minutes

1

The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient

atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.

Minimum dry time

1

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

MRI INFORMATION

MR Conditional

The Infinity™ OCT System was determined to be MR Conditional based on comparison to previously evaluated Medtronic
products. A patient with this device can be safely scanned immediately after device placement under the following conditions:

▪ Static magnetic field of 1.5 Tesla or 3.0 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 gauss/cm (30 T/m).
▪ Maximum MR system reported whole body averaged specific absorption rate (SAR) of <2W/kg (Normal Operating Mode)

for a continuous 6 minutes of scanning per pulse sequence within a quadrature whole-body radiofrequency transmit coil.

Under the scan conditions defined, a worst case posterior occipitocervical-upper thoracic system representative of the Infinity™
OCT System produced a maximum temperature rise of less than 6.8°C after 6 minutes of continuous scanning. MR image
quality may be compromised if the area of interest is in the same area or relatively close to the position of the Infinity™ OCT
System. The image artifact extends approximately 25mm from the device when imaged with a gradient echo pulse sequence in
a 3.0 T MRI system.

The presence of other implants or the health state of the patient may require a modification of the MR conditions.

MRI Patient Counseling Information

Physicians should communicate with the patient the following information about MRI with respect to the Infinity™ OCT System:

▪ Infinity™ OCT System performance has been established for MRI systems at field strengths of 1.5 Tesla and 3.0 Tesla.
▪ During an MRI, the patient may notice a warming sensation around the implant or feel a tingling sensation. If the warming or

tingling sensation is uncomfortable, the patient should communicate this to the MR technologist, the MRI should be
stopped, and the settings adjusted to reduce or eliminate the sensation. The highest temperature change observed in non­clinical testing was 6.8ºC (associated with specific conditions previously listed).

▪ Additionally, the metal in the implant may cause the MRI image to be distorted in the area around the implant. The MRI can

be adjusted to minimize the image distortion.

Physicians should instruct patients to:

▪ Inform any healthcare personnel (e.g. doctor or MR technologist) they have an implanted posterior cervical-thorasic fusion

device prior to receiving an MRI.

▪ The patient’s doctor will recommend whether or not an MRI is appropriate.

If the Infinity™ OCT System is used in connection with any other device which is not MR Conditional, be advised this
combination has not been evaluated in the MR environment and, therefore, higher heating and possible injury to the patient may
occur.

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is needed or required, contact Medtronic.

©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

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

Do not re-use

Batch code

Manufacturer

Catalogue number

Non-sterile

For US audiences only

The Device complies with European Directive MDD
93/42/EEC

Sterilized using irradiation

Use-by date

MR Conditional

Consult instructions for use at this website.