INDICATIONS, SAFETY, AND WARNINGS CLYDESDALE SPINAL SYSTEM

PURPOSE

This device is a PEEK (POLYETHERETHERKETONE) interbody fusion device intended for stabilization use 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 who is thoroughly knowledgeable in the implant’s material and surgical aspects and who has been instructed as to its mechanical and material applications and limitations.

DESCRIPTION

The CLYDESDALE® Spinal System consists of PEEK cages of various widths and heights, which include Tantalum markers. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. The hollow 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, or INFUSE® Bone Graft as designated below.

Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded.

INDICATIONS

The CLYDESDALE® Spinal System is intended to be used in interbody 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. When used for these indications, the CLYDESDALE® Spinal System is intended for use with supplemental fixation systems cleared for use in the lumbar spine.

Certain sizes of the CLYDESDALE® Spinal System may be used with INFUSE® Bone Graft in single-level Oblique Lateral Interbody Fusion (OLIF) procedures from L2 to L5 in patients diagnosed with DDD, as defined above. Consult the labeling for the INFUSE® Bone Graft/Medtronic Interbody Fusion Device for information on the specific sizes of the CLYDESDALE® Spinal System approved for use with INFUSE® Bone Graft, as well as specific information regarding contraindications, warnings, and precautions associated with INFUSE® Bone Graft. INFUSE® Bone Graft is not indicated for use in a direct lateral interbody fusion (DLIF) surgical approach.

Additionally, the CLYDESDALE® Spinal System can be used to provide anterior column support in patients diagnosed with degenerative scoliosis as an adjunct to pedicle screw fixation. INFUSE® Bone Graft is not indicated for use in patients with this condition.

These patients should be skeletally mature and have had six months of nonoperative treatment. The CLYDESDALE® Spinal System is intended to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion. These implants may be implanted via a minimally invasive lateral approach.

CONTRAINDICATIONS

This device is not intended for cervical spine use.

Contraindications include, but are not limited to:

  • 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.
  • Pediatric cases or 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 utilization 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 potential 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 but are not limited to:

  • 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.
  • 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 AND PRECAUTIONS

Warning: 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. 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 the implants are important considerations in the successful utilization of the system by the surgeon. Further, the proper selection and the compliance of the patient will greatly affect the results. Patients who smoke have been 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 with a previous surgery.

A device that has been implanted should never be reused, reprocessed, or resterilized under any circumstances. Sterile packaged devices should also never be resterilized. Reuse, reprocessing, or resterilization 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. 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.

MRI INFORMATION

MR Conditional

The CLYDESDALE® Spinal 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

  • Static magnetic field of 1.5 Tesla and 3.0 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, a worst case interbody device representative of the CLYDESDALE® Spinal System produced the following temperature rises 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 systems:

 

1.5 Tesla

3.0 Tesla

MR system reported, whole body averaged SAR

2.9 W/kg

2.9 W/kg

Calorimetry measured values, whole body averaged SAR

2.1 W/kg

2.7 W/kg

Highest temperature change

1.8˚C

1.7˚C°

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 CLYDESDALE® Spinal System. Therefore, optimization of MR imaging parameters to compensate for the presence of this device may be necessary.

MRI Patient Counseling Information

Physicians should communicate with the patient of the following information about MRI with respect to the CLYDESDALE®

Spinal System:

  • CLYDESDALE® 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 they have an implanted interbody device prior to receiving an MRI.
  • The patient’s doctor will recommend whether or not an MRI is appropriate.

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

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. 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 a CLYDESDALE® Spinal System 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 aforementioned 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.
  • Further information about this system will be provided upon request.
  • The surgeon should be familiar with the various devices before use and should personally verify all devices are present before the surgery begins.
  • The size of device for the case should be determined prior to beginning the 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 supplied sterile, all devices should be cleaned and sterilized before use. Additional sterile components should be available in case of any unexpected need.

INTRAOPERATIVE

  • The instructions in any available CLYDESDALE® 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, autograft and/or allogenic 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. 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.
  • CLYDESDALE® Spinal System 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

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. 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 that there is no damage prior to use. Damaged packages or products should not be used, and should be returned to Medtronic.

CLEANING

Disassembly/reassembly and cleaning instructions can be found at http://manuals.medtronic.com/. Refer to the “Reprocessing Instructions for the Direct Lateral (DL) Inserter–M708348B087” for disassembly and cleaning instructions specific to the DL Inserter instrument (part number 2942001). Refer to the “Reprocessing Instructions for the General Instruments” 0380035 for cleaning instructions for CLYDESDALE® Spinal System trials.

STERILIZATION

The CLYDESDALE® Spinal System implants are supplied in a sterile form. Never autoclave or in any other way attempt to resterilize or re-use the CLYDESDALE® Spinal System implants. Instruments are provided non-sterile and must be sterilized by the hospital prior to surgical 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 following sets of process parameters:

Table 1: Sterilization Cycle Parameters for the United States and Its Territories

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

MINIMUM DRY TIME1

Steam

Gravity Displacement

250°F (121°C)

30 Minutes

30 Minutes

Steam

Gravity Displacement

270°F (132°C)

15 Minutes

30 Minutes

Steam

Gravity Displacement

275°F (135°C)

10 Minutes

30 Minutes

Steam

Dynamic-Air-Removal

270°F (132°C)

4 Minutes

30 Minutes

Steam

Dynamic-Air-Removal

275°F (135°C)

3 Minutes

16 Minutes

For medical facilities located outside the US and its territories: Some non-US health care authorities recommend sterilization according to these parameters so as to minimize the potential risk of transmission of Creutzfeldt-Jakob disease, especially of surgical instruments that could come into contact with the central nervous system.

Table 2: Table 2: Sterilization Cycle Parameters for Medical Facilities Outside the United States and Its Territories

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

MINIMUM DRY TIME1

Steam

Gravity Displacement

273°F (134°C)

20 Minutes

30 Minutes

Steam

Dynamic-Air-Removal

273°F (134°C)

4 Minutes

30 Minutes

Steam

Dynamic-Air-Removal

273°F (134°C)

20 Minutes

30 Minutes


1The minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambien atmospheric pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.

NOTE: Because of the many variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g., temperatures, exposure times) used for their equipment.

The sterilization cycles listed in Table 2 are not considered by the Food and Drug Administration (FDA) to be standard sterilization cycles. 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) that have been cleared by the FDA for the selected sterilization cycle specifications (time and temperature).

Sterilization instructions can be found at http://manuals.medtronic.com/. Refer to the “Reprocessing Instructions for the Direct Lateral (DL) Inserter– M708348B087” for the sterilization instructions specific to the DL Inserter instrument (part number 2942001). Refer to the “Reprocessing Instructions for the General Instruments” 0380035 for sterilization instructions for CLYDESDALE® Spinal System trials.

SERVICING

Inspect all instruments prior to use. Return the instrument to Medtronic if any of the following are observed: corrosion, discoloring, pitting, or any other signs of wear.

Inspect the threaded shaft of the inserter instrument. Return the instrument to Medtronic if threads are damaged or distorted or if the shaft appears bent.

Inspect the silicone handle of the inserter instrument. Return the instrument to Medtronic if the silicone handle is discolored, cut, or damaged in any way.

PRODUCT COMPLAINTS

Any health care professional (e.g., customer or user of this system of products) who has any complaints or who has experienced any dissatisfaction in the product quality, identity, durability, reliability, safety, effectiveness, and/or performance, should notify the distributor or Medtronic. Further, if any of the implanted spinal system component(s) ever “malfunctions” (i.e., does not meet any of its performance specifications or otherwise does not perform as intended), or is suspected of doing so, the distributor should be notified immediately. If any Medtronic product ever malfunctions and may have caused or contributed to the death or serious injury of a patient, the distributor should be notified immediately by telephone, fax, or written correspondence. When filing a complaint, provide the component(s) name and number, lot number(s), your name and address, the nature of the complaint, and notification of whether or not a written report from the distributor is requested.

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. Covered by one or more of U.S. Pat. Nos. 5,772,661; 5,860,973; 6,991,654; 7,125,425; and other pending patent applications.

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