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.