Safety Information

Prescribing Statement

The M6-C™ Artificial Cervical Disc is indicated for reconstruction of the disc following single level discectomy in skeletally mature patients with intractable degenerative cervical radiculopathy with or without spinal cord compression at one level from C3 – C7. The M6-C™ Artificial Cervical Disc is implanted via an anterior approach.

Warning:  The M6-C™ Artificial Cervical 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 experience and/or training may lead to a higher incidence of adverse events, such as vascular or neurological complications.

Patients should be instructed in postoperative care procedures and should be advised of the importance of adhering to these procedures for successful treatment with the device including the avoidance of heavy lifting, repetitive bending, and prolonged or strenuous activity initially and for a period of weeks to months depending on the individual patient’s progress and the stability and functioning of the implant.

Potential adverse effects of the device on health include paralysis or death.  Read the full prescribing information for important contraindications and all warning, precautions, and instructions for use.  Full prescribing information can be found at M6disc.com or by calling 1‐888‐298‐5700.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

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 through MRI, CT or X-rays.
  • Your doctor may have diagnosed you with cervical disc degeneration, 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. Use the Find a Physician locator and talk to a doctor about the benefits and risks of artificial disc replacement.

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

If you have been diagnosed with or are experiencing any of the following conditions, it is recommended that you do not receive the M6-C disc:

  • An active systemic (whole body) infection or infection at the surgery site
  • A known allergy to the materials the device is made from, including titanium, stainless steel, polyurethane, polyethylene or ethylene oxide residuals
  • Advanced abnormal changes at the proposed surgery level
  • History of osteoporosis or weak bone structure
  • An unnatural shape (deformity) of the spine at the proposed surgery level or the level above or below
  • Advanced degeneration to the joints (facets) on the back of the vertebrae

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 disc has not been established in patients with the following conditions:

  • Patients younger than 18 years old
  • More than one cervical spine level requiring surgery
  • 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 > 40)

Instructions for Use

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

Download IFU

More Information on Neck and Arm Pain

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