Safety Information

Who is a Candidate for the M6-C Artificial Cervical Disc?

The M6-C™ artificial cervical disc may be the right choice for you if the following statements are true:

  • You have pain, weakness, numbness or tingling in your neck, shoulders, arms or hands
  • Your doctor has diagnosed you with cervical disc damage at any one or multiple levels between C3 and C7 through MRI, CT or X-rays.
  • Your doctor may have diagnosed you with cervical disc disease, ruptured or herniated disc (herniated nucleus pulposus), bone spurs (osteophytes), or degeneration of the spine from wear and tear
  • You are 18 years or older
  • You have already tried medications and physical therapy with unsuccessful results, or you have symptoms that your condition is worsening

If these statements are true, then you may be a candidate for the M6-C disc. Talk to your surgeon to determine if you are a candidate for the M6-C artificial cervical disc.

NOTE: Approved indications for use, contraindications, warnings and precautions may vary among different regions/countries where the M6-C disc is distributed. Please consult your physician to determine if you are a candidate for the M6-C artificial cervical disc.

Who is Not a Candidate for the M6-C Disc?

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

  • Are 70 years of age or older
  • Have a bone mineral density with T-score ≤-1.5 as determined by spine DXA if male is more than 60 years of age or female is more than 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 two weeks of the planned date of the index surgery
  • Have any medical or surgical condition precluding the potential benefit of spinal 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
  • Have spinal metastases
  • Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals
  • Have type 1 or type 2 diabetes requiring daily insulin management
  • Are pregnant
  • Have axial neck pain as the solitary symptom
  • Have severe cervical myelopathy as evidenced by any sign of gait disturbance, unilateral or bilateral leg weakness, and/or uncontrollable bowel/bladder symptoms related to cervical spine disease
  • Require a treatment (e.g., posterior element decompression) that destabilizes the spine
  • Have advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative site
  • Have advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by:
    • Bridging osteophytes
    • Average ROM <4º
    • Disc height <25 percent of the AP width of the inferior vertebral body; as measured in a lateral radiograph in neutral position
    • Subluxation >3mm
    • Kyphotic deformity at >20º on neutral radiographs

What are the Warnings Associated with the M6-C Disc?

As with all surgeries there are potential risks, including but not limited to those listed below. Speak with your doctor to learn more about risks specific to the M6-C disc surgery.

  • Correct placement of the M6-C disc is essential to achieving a desired outcome.
  • The M6-C disc should only be used by surgeons who are experienced in the surgical procedure and have undergone adequate training with this device.
  • A lack of adequate surgeon experience and/or training may lead to a higher incidence of adverse events, such as vascular or neurological complications.
  • X-rays must be taken during the surgical procedure. Failure to take appropriate X-rays during the M6-C disc surgery may result in patient injury.
  • Advancement of the surgical instruments or the M6-C disc beyond the back border of the vertebral bodies may result in surgical complications.

What are the Precautions Associated with the M6-C Disc?

The safety and effectiveness of the M6-C artificial cervical disc has not been established in patients with the following conditions:

  • Patients younger than 18 years old
  • Previous surgery at the spine level currently requiring surgery
  • Soreness of the neck muscles as the only symptom
  • Prior surgery causing an unstable cervical spine
  • Very limited forward/backward motion at the surgery level
  • Unstable spine at the surgery level or at the level above or below
  • Diseases of the bone that affect bone development or mineral levels
  • Taking medications that may interfere with bony/soft tissue healing including chronic steroid use
  • Insulin-dependent diabetes
  • Extremely overweight patients (Body Mass Index > 30)
  • Additional precautions as described in the M6-C artificial cervical disc Instructions For Use

Instructions for Use

Download the IFU for full information on instructions for use, contraindications, warnings, precautions, adverse reactions, and sterilization.

Download IFU

More Information on Neck and Arm Pain

Learn more about the M6-C procedure, its benefits, and recovery time.