Safety Information About the M6-C Artificial Cervical Disc

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.

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.

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.