Medtronic 2968001 Instructions for Use

Adaptix™ Interbody System with

M333023W072E Rev. B

Titan nanoLOCK™ Surface
Technology

2020-09-15

IMPORTANT INFORMATION ON THE ADAPTIX™ INTERBODY SYSTEM WITH TITAN
NANOLOCK™ SURFACE TECHNOLOGY

Note: not all parts may be available in each geography.

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 Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology consists of additive manufactured titanium cages
of various lengths and heights 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. The open geometry of the
implants allows them to be packed with autograft bone graft and/or allogenic bone graft comprised of cancellous and/or
corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate. The interbody device is treated with
Titan Surface Technologies™, where nanoLOCK™ Surface Technology (MMN™) is designed to improve fixation to the
adjacent bone. The nanoLOCK™ Surface Technology (MMN™) provides a microscopic-roughened surface with nano-scale
features. The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended for use with supplemental
fixation systems cleared for use in the lumbar spine.

Stainless steel and titanium implants are not compatible. They must not be used together in a construct. As with all orthopedic
implants, in no case may the implants be re-used.

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

INDICATIONS

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is intended to be used in spinal fusion procedures
for patients diagnosed with Degenerative Disc Disease (DDD) at one or two 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. The Adaptix™ Interbody System with Titan
nanoLOCK™ Surface Technology is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

These patients should be skeletally mature and have had six months of nonoperative treatment. The Adaptix™ Interbody
System with Titan nanoLOCK™ Surface Technology is intended to be used with autograft and/or allogenic bone graft comprised
of cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate. These
implants may be implanted via an open or a minimally invasive posterior approach and/or transforaminal approach.

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.

▪ 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 the 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 or quality.
▪ 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:

▪ 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.

▪ 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.

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 the results. Use of this product without bone graft 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.

A device that has been implanted should never be re-used or re-processed under any circumstances. Sterile packaged devices
are never to be re-sterilized.

Reuse or reprocessing of single use devices 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.

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.

IMPLANT SELECTION

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

DEVICE FIXATION

Installation and positional adjustment of implants must only be done with special ancillary instruments and equipment supplied
and designated by Medtronic. In the interests of patient safety, it is therefore recommended that Medtronic implants are not
used with devices from any other source.

Never, under any circumstances, reuse an Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology device.
Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early
breakage.

PREOPERATIVE

▪ Only patients that meet the criteria described in the indications should be selected.
▪ Patient conditions and/or predispositions such as those addressed in the contraindications should be avoided.
▪ Care should be taken in the handling and storage of the device(s). They should not be scratched or damaged. Devices

should be protected during storage especially from corrosive environments.

▪ The surgeon should be familiar with the various devices before use and should personally verify all devices are present

before surgery.

▪ The size of device for the case should be determined prior to surgery. An adequate inventory of implant sizes should be

available at the time of surgery, including sizes larger and smaller than those expected to be used.

▪ Instruments will be cleaned and sterilized before use. Additional sterile implants and instruments should be available in

case of an unexpected need.

INTRAOPERATIVE

▪ Instructions in any available Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology surgical technique

manual should be carefully followed.

▪ At all times, extreme caution should be used around the spinal cord and nerve roots. Damage to the spinal cord and/or

nerves will cause loss of neurological functions.

▪ Breakage, slippage, or misuse of instruments or implants may cause injury to the patient or operative personnel.
▪ To ensure proper fusion below and around the location of the fusion, autogenous bone graft and/or allogenic bone graft

comprised of cancellous and/or corticocancellous bone and/or demineralized allograft bone with bone marrow aspirate must
be used.

▪ Bone cement should not be used because this material may make removal of these components difficult or impossible.

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. The patient must be warned

that loosening, and/or breakage of the device(s) are complications which may occur as result of early or excessive weight­bearing, muscular activity, or sudden jolts or shock to the spine.

▪ The patient should be advised not to smoke or consume excess alcohol during period of the bone fusion process.
▪ The patient should be advised of the inability to bend at the point of spinal fusion and taught to compensate for this

permanent physical restriction in body motion.

▪ It is important that immobilization of union is established and confirmed by roentgenographic examination. If a non-union

develops or if the components loosen, migrate, and/or break, the devices should be revised and/or removed immediately
before serious injury occurs.

▪ Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology implants are interbody devices and are intended

to stabilize the operative area during the fusion process.

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

PACKAGING

Implants are supplied in a sterile form. Visually inspect all packaging before us. Packages should be intact upon receipt. Once
the seal on the sterile package has been broken, the product should not be used or re-sterilized. If a loaner or consignment
system is used, all sets should be carefully checked for completeness and all components including instruments 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

Implants are provided sterile and should only be used if they are marked sterile and clearly labeled as such in an unopened
sterile package provided by the company. Only sterile products should be placed in the operative field.

CLEANING AND DECONTAMINATION

Instruments have reprocessing instructions enclosed within the product packaging. Refer to these detailed instructions for
further information on the general considerations, cleaning, and sterilization procedures. These reprocessing instructions can
also be found at http://manuals.medtronic.com/ according to the product part number.

PRODUCT COMPLAINTS

To report any product problems, contact Medtronic.

MRI INFORMATION

MR Conditional

The Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 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 of 1.5 and 3.0 Tesla.
▪ Maximum spatial gradient magnetic field of 3000 Gauss/cm (30 T/m) or less.
▪ Maximum whole-body average specific absorption rate (SAR) of 2.0-W/kg under normal operating mode for 15 minutes of

scanning per pulse sequence.

Under the scan conditions defined, a worst-case interbody fusion device representative of the Adaptix™ Interbody System with
Titan nanoLOCK™ Surface Technology produced a maximum temperature rise <5.0°C after 15 minutes of continuous
scanning.

In non-clinical testing, the image artifact caused by a worst-case interbody fusion device representative of the Adaptix™
Interbody System with Titan nanoLOCK™ Surface Technology extends approximately 13mm for a spin echo sequence and
23mm for a gradient echo sequence in a 3 Tesla MR system.

Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.
If the Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology is used in connection with any device which is

not MR Conditional, be advised this combination was not tested in the MR environment and, therefore, higher heating and
possible injury to the patient may occur. The presence of other implants or the health state of the patient may require a
modification of the MR conditions.

FURTHER INFORMATION

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

©2020 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]

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

Medtronic B.V.

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

Manufacturer

Catalogue number

For US audiences only

This device complies with applicable European Union
regulations and directives.

This device complies with applicable European Union
regulations and directives.

Sterilized using irradiation

Use-by date

MR Conditional

Consult instructions for use at this website.

Medical device

Single sterile barrier system

Double sterile barrier system

Single sterile barrier system with protective packaging
inside

Single sterile barrier system with protective packaging
outside