INDICATIONS, SAFETY, AND WARNINGS SOVEREIGN Spinal System

PURPOSE

The SOVEREIGN™ Spinal System is a fusion system 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. This system may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

DESCRIPTION

The SOVEREIGN™ Spinal System is an intervertebral body fusion device with internal screw fixation. The screws protrude through the interbody portion of the device and stabilize the vertebral body while preventing expulsion of the implant. The implant is lens-shaped with 3 holes for placement of titanium screws using an anterior or oblique approach. The SOVEREIGN™ Spinal System contains both a fixed and a variable angle screw option. The fixed angle screw option provides an interference fit with the PEEK interbody implant. The variable angle screw option provides a slight clearance between the PEEK interbody implant and the screw which allows for a small amount of variable screw angulation. This system is intended to be radiolucent and the interior space of the product is to be used with autogenous bone graft. The accompanying cover plate is designed to resist screw backout and must be used when the variable angle screws are implanted.

The SOVEREIGN™ Spinal System interbody device is manufactured from PEEK (polyetheretherketone) and contains tantalum radiopaque markers. The screws used with this device are manufactured from titanium alloy.

INDICATIONS

The SOVEREIGN™ Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Additionally, the SOVEREIGN™ Spinal System is indicated for use in patients diagnosed with deformity conditions as an adjunct to fusion. These patients should be skeletally mature and have had 6 months of non-operative treatment. The SOVEREIGN™ Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. These implants may be implanted via a variety of open or minimally invasive approaches. These approaches include anterior and oblique.

The SOVEREIGN™ interbody system may be used as a stand-alone device or in conjunction with supplemental fixation. When used as a stand-alone device, the SOVEREIGN™ interbody device is intended to be used with 3 titanium alloy fixed or variable angle screws. The accompanying cover plate MUST be used anytime the device is used with any number of variable

angle screws. If the physician chooses to use less than 3 or none of the provided screws, additional supplemental fixation in the lumbar spine must be used to augment stability. Implants with lordosis angles greater than 18° are intended to be used with supplemental fixation (e.g. facet screws or posterior fixation).

CONTRAINDICATIONS

This device is not intended for cervical spine use. Contraindications include:

• Any case where there is translational instability (spondylolisthesis of any grade or retrolisthesis) at the level treated unless posterior supplemental fixation is used to augment
• Any case where posterior elements were removed such that it introduces instability at the level(s) treated unless posterior supplemental fixation is used to augment stability.
• Severe osteoporosis.
• Any patient having inadequate tissue coverage over the operative site or inadequate bone stock or quality.
• 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 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.
• Any case where the implants would be too large or too small to achieve a successful result.
• Any case that requires the mixing of metals from 2 different components or systems.
• 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:

• Osteoporosis unless posterior supplemental fixation is used to augment stability.
• Severe bone resorption.
• Osteomalacia.

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.
• Foreign body reaction to the implants including possible tumor formation, auto immune disease, and/or scarring.
• Pressure on the surrounding tissues or organs.
• Damage to the peritoneum.
• 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.
• Damage to the anterior vasculature.
• 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 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.
• 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

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. Supplemental fixation systems which may be used with this device include: the CD HORIZON™ Spinal System, the TSRH™ Spinal System, the DYNALOK™ Classic Spinal System, the Z-PLATE II™ Anterior Fixation System, the PYRAMID™ Anterior Plate Fixation System, and/or their successors. When additional support instrumentation is used, refer to the package insert for requirements and limitations related to those devices.

Patients with previous spinal surgery at the levels to be treated may have different clinical outcomes compared to those without a previous spinal surgery.

Use of this product without autogenous bone graft may 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, proper selection and placement of the implant, and good reduction are important considerations in the success of surgery.

Never reuse an internal fixation device under any circumstances. Even when a removed device appears undamaged, it may have small defects or internal stress patterns that may lead to early breakage. Damage of the thread will reduce the stability of the instrumentation. Any retrieved devices should be treated in such a manner that reuse in another surgical procedure is not possible.

A device that has been implanted should never be reprocessed or reused under any circumstances. Sterile packaged devices should also never be resterilized. Reprocessing or reuse may compromise the structural integrity of these implants and create a risk of contamination of the implants which could result in patient injury, illness, or death.

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 alcohol abuse patients are also poor candidates for spine fusion.

PRECAUTIONS

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. Plastic polymer 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 material 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

• Care should be used in the handling and storage of the implant components. The implants should not be scratched or damaged. Implants and instruments should be protected during storage especially from corrosive environments.
• 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 surgery.
• The type of construct to be assembled 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.
• Unless sterile packaged, all implants should be sterilized before Additional sterile implants should be available in case of an unexpected need.

INTRAOPERATIVE

• The instructions in any available SOVEREIGN™ Spinal System 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 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 must be used.
• Bone cement should not be used because this material may make removal of these components difficult or impossible. The heat generated from the curing process may damage or deform the PEEK devices.

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, or breakage of the device are complications which can occur as a result of excessive 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, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting devices. The patient should be warned to avoid falls or sudden jolts in spinal position.
• To allow the maximum chances for a successful surgical result, the patient or device should not be exposed to mechanical vibrations 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 or consume excess alcohol during the autogenous bone graft healing process.
• Patients should be advised of their inability to bend 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 eventual bending, loosening, or breakage of the device. It is important that immobilization of the union is established and confirmed by roentgenographic examination. Where there is a non-union, or if the components loosen, bend, and/or break, the device should be revised and/or removed immediately before serious injury occurs.

MRI INFORMATION

MR Conditional
In non-clinical testing the SOVEREIGN™ Spinal System was determined to be MR Conditional. A patient with this device can be scanned safely, immediately after placement under the following conditions:

Static Magnetic Field

• Static magnetic field of 1.5 Tesla and 3 Tesla.
• Maximum spatial gradient magnetic field of 3000 Gauss/cm or less.
• Maximum whole body average specific absorption rate (SAR) of 2.0 W/kg or less under Normal Operating Mode for 15 minutes of scanning per pulse sequence.

MRI-Related Heating

In non-clinical testing, the SOVEREIGN™ Spinal System produced the following temperature rise during an MRI (Magnetic Resonance Imaging) performed for 15 minutes of scanning (i.e. per pulse sequence) in 1.5 Tesla/64 MHz MR system (Magnetom, Siemens Medical Solutions, Malvern, PA. Software Numaris/4, Version Syngo MR 2002B DHHS Active –shielded, horizontal field scanner) and 3 Tesla/128 MHz, (Excite, HDx, Software 14X.M5, General Electric Healthcare, Milwaukee, WI) MR system:

Artifact Information

MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the SOVEREIGN™ Spinal System. The artifact size information follows:

Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary. The maximum artifact size (i.e. as seen on the gradient echo pulse sequence) extends approximately 20mm relative to the size and shape of the SOVEREIGN™ Spinal System.

MRI Patient Counseling Information

Physicians should communicate with the patient the following information about MRI with respect to the SOVEREIGN™ Spinal System:

• SOVEREIGN™ Spinal 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 non- clinical testing was +1.8ºC (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) that an implanted interbody device exists prior to receiving an MRI.
• The patient’s doctor will recommend whether or not an MRI is appropriate.

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

PACKAGING

Devices may be supplied in a sterile or non-sterile form. Packages for each of the components should be intact upon receipt. Once the seal on the sterile package has been broken, the product should not be re-sterilized. 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 by the hospital 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

¹The 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.

Note: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The sterilization parameters listed in Tables 1 and 2 can be achieved in both health care facility and larger, industrial sterilizer models. 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.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.

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.

Medtronic Sofamor Danek USA, Inc.
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