Orthofix M6-L SpinalKinetics Artificial Lumber Disc Instructions

Orthofix M6-L SpinalKinetics Artificial Lumber Disc

The Spinal Kinetics M6®-L Artificial Lumbar Disc is intended to be used with the Spinal Kinetics M6-L Artificial Lumbar Disc Instruments. Refer to the Spinal Kinetics M6-L Artificial Lumbar Disc Surgical Technique Manual for implantation instructions.

Description

The Spinal Kinetics M6-L Artificial Lumbar Disc is an intervertebral disc prosthesis designed to maintain motion of a functional spinal unit in the lumbar spine when the native disc is diseased.
The M6-L Artificial Disc is designed to maintain the natural behavior of a functional spinal unit by replicating the biomechanical characteristics of the native disc. The core of the disc is composed of a polycarbonate urethane polymer material. It is surrounded by a polyethylene fiber construct. The device is comprised of an assembly of ultra-high molecular weight polyethylene (UHMWPE) fibers wound in multiple redundant layers around a polycarbonate urethane polymer (PCU) core and through titanium alloy endplates. Biomechanical studies demonstrate that this unique design provides progressive resistance to motion, leading to physiologic motion in flexion, extension, lateral bending, and axial rotation as well as in compression and shear. The prosthetic disc also has a PCU sheath surrounding the core and fiber construct designed to minimize any tissue ingrowth as well as the migration of wear debris. Serrated keels located on the exterior surfaces of the device provide acute fixation to the superior and inferior vertebral bodies. Both the endplates and keels are coated with porous titanium to increase bone contact surface area and promote osseointegration.

Indications for Use

The Spinal Kinetics M6-L Artificial Lumbar Disc System is intended for use in skeletally mature patients undergoing primary surgery for treatment of symptomatic degenerative disc disease (DDD) of the lumbar spine at any one level or two adjacent levels between L3 through S1, who have not responded to at least 6 months of non-operative, conservative management. The DDD patient may also have up to 3mm of spondylolisthesis at the involved level. The disease state is demonstrated by signs and/or symptoms of disc herniation, osteophyte formation, or loss of disc height.

Contraindications

The M6-L should not be implanted in patients with the following conditions:

• Be >75 years of age, or < 18 years of age
• Osteopenia or osteoporosis is defined as a bone mineral density with a T-score ≤-1.5 as determined by spine DXA if male ≥60 years of age or female ≥50 years of age
• Have an active systemic infection or infection at the operative site
• Have sustained an osteoporotic fracture of the spine, hip, or wrist
• Have received medications (e.g. methotrexate, alendronate) that interfere with bone and mineral metabolism within 2 weeks of the planned date of the index surgery
• Have a history of endocrine or metabolic disorders (e.g., Paget’s disease) known to affect bone and mineral metabolism
• Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis
• Prior intra-abdominal or retroperitoneal surgery would make the approach prohibitively dangerous
• Prior anterior surgery at the same level
• Spinal metastases
• Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals.
• Have uncontrolled insulin-dependent type 1 or type 2 diabetes
• Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
• Bony lumbar stenosis
• Isolated radicular compression syndromes, especially due to disc herniation
• Pars defect
• Increased segmental instability
• Spinal deformities, spondylolisthesis above 3mm at the involved level(s)
• Radiological confirmation of severe facet joint disease or degeneration

Precautions

• Read and understand the M6-L Artificial Lumbar Disc System Instructions for Use prior to using.

• Correct placement of the device is essential to optimal performance. Use of the M6-L Total Disc Replacement should only be undertaken after the surgeon has become thoroughly knowledgeable about spinal anatomy and biomechanics; has had experience with anterior approach spinal surgeries, and has had hands-on training in the use of this device.

• The trial, chiseling, and insertion steps for the device must be performed under fluoroscopic visualization. Extreme care must be taken to avoid placing the device or any instrument beyond the posterior edge of either vertebral body. The user must maintain control and visual reference via fluoroscopy. Failure to visualize the trial, chiseling, and insertion steps could result in patient injury.

• Ensure that the appropriate size M6-L is chosen. Using an inappropriately sized M6-L may result in less than optimal clinical outcomes. Proper sizing should be determined in accordance with the Spinal Kinetics M6-L Artificial Lumbar Disc Surgical Technique Manual.

• The M6-L must be implanted using the Spinal Kinetics lumbar instrumentation only. The use of the Spinal Kinetics instruments for purposes other than those for which they are intended may result in damaged or broken instruments. Do not use any other implant components or instrumentation. Refer to the Spinal Kinetics M6-L Artificial Lumbar Disc Surgical Technique Manual for implantation instructions.

• The M6-L instruments are reusable, supplied non-sterile, and must be sterilized in accordance with the recommended cleaning and sterilization procedures. (See “Care And Handling Instructions – Manual Surgical Instruments, PK 0234)

• Improper surgical use and technique may lead to suboptimal clinical outcomes.

• Postoperative rehabilitation and restrictions must be reviewed with the patient prior to discharge from the hospital.

• The manufacturer is not responsible for any complications arising from an incorrect diagnosis, choice of incorrect M6-L, incorrect surgical techniques, including improper use of instruments, the limitations of treatment methods, or inadequate asepsis.

• Excessive removal of subchondral bone during the preparation of the vertebral endplates may
  lead to less than optimal clinical outcomes and is not recommended.

• The M6-L cannot be re-positioned in an anterior direction without complete removal. Take care not to place the M6-L too posterior.

• Take care not to over-distract the disc space.

• Adequately instruct the patient on postoperative rehabilitation and limitations. Postoperative care and the patient’s ability and willingness to follow instructions are two of the most important aspects of successful osseointegration of the implant. The patient must be made aware of the limitations of the implant and that early strenuous physical activity and high load-bearing have been implicated in the premature loosening of fixation prior to proper integration. An active, debilitated, or uncooperative patient who cannot properly restrict activities may be at particular risk during postoperative rehabilitation.

• Physicians should instruct patients to contact a surgeon in the event of a

• significant increase in pain which may indicate a device performance issue.

• The M6-L Artificial Disc has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating or migration in the MR environment.

Potential Risks and Adverse Events

• Adverse/allergic reaction to implant materials
• M6-L migration in the anterior-posterior direction
• M6-L subsidence requiring subsequent surgical intervention
• Placement difficulties requiring acute implant removal
• Excessive facet loading
• Kyphosis or hyper-extension
• Loss of flexibility
• The asymmetric range of motion
• Spondylotic bridging
• Vertebral body fracture
• Infection
• Spinal cord damage
• Neurologic damage or failure to relieve symptoms
• Implant Failure
  • M6-L instability leading to unstable movement of the spine
  • Separation of M6-L components
  • Excessive M6-L height loss requiring subsequent surgical intervention
  • Wear debris
  • Material degradation
• Risks associated with general and spine surgery include:
  • Excessive bleeding
  • Anesthesia reaction
  • Respiratory disorders
  • Heart attack
  • Nerve or spinal cord damage leading to sensory loss
  • Pneumonia
  • Blood mass/clot
  • Side effects from medicine used during and after surgery
  • Scarring of the spinal canal sheath
  • Bruising
  • Damage to blood vessels near the spine
  • Opening of the wound
  • Loss of fluid surrounding the spinal cord
  • Stroke
  • Superficial or deep wound infection
  • Accumulation of fluid within the incision
  • Additional surgery
  • Incorrect treatment level
  • Ongoing pain
  • Spinal fractures

How Supplied

• The M6-L lumbar disc is supplied sterile and is single use only. Do not re-sterilize or reuse the M6-L. Re-sterilizing and/or reusing the M6-L may result in impaired performance and could cause patient injury and/or the communication of infectious diseases between patients.
• Do not use the M6-L after the last day of the month of the “Use by date” on the label.
• Inspect the device package before opening it. Do not use if the package is damaged or shows any evidence of breached packaging, compromised device sterility, or storage above 60˚ C (140˚F). The temperature recorder label on the box turns black if the product has reached 60˚ C (140˚ F).
• Use the sterile technique to carefully remove the disc from the packaging. Inspect the M6-L to ensure it exhibits no signs of damage (e.g., metal and plastic damage).
• Once removed from the package, keep the M6-L from coming into contact with any cloth, sponges or other foreign material that may become attached to the Titanium Plasma Spray Coating of the endplates.
• The M6-L serial number and the size must be documented for each patient record.

Device Retrieval

Should it be necessary to remove a M6-L Artificial Disc, please contact Spinal Kinetics to receive instructions regarding the data collection, including histopathological, mechanical, and adverse event information. Please refer to the M6-L Surgical Technique Manual for step-by-step instructions on the required surgical technique for device retrieval. All explanted devices must be returned to Spinal Kinetics for analysis.
Please note that the artificial disc should be retrieved as carefully as possible in order to keep the Implant and surrounding tissue intact. Also please provide descriptive information about the gross appearance of the device in situ, as well as descriptions of the removal methods, e.g. intact or in pieces.

Limited Warranty

Spinal Kinetics, Inc. warrants that reasonable care has been used in the manufacture of this device. There are no express or implied warranties, including fitness for a particular purpose, for this M6-L System. Any description or specifications provided are sole to describe the product at the time of manufacture and do not constitute any express or implied warranties. Spinal Kinetics, Inc. is not responsible for any direct, incidental, special, or consequential loss, damage, or expense based on any defect, failure, or malfunction of this product, other than as expressly provided by mandatory provisions of applicable law. No person has the authority to bind Spinal Kinetics, Inc. to any representation or warranty except as provided in this Limited Warranty.

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