Mobi-C

The FDA IDE Trial results showed that Mobi-C is statistically superior to ACDF at 60 months for overall trial success and a safe and effective surgical option at one-level. Dr. Hyun Bae presented 24-month data comparing the Mobi-C cervical disc to ACDF at the 2014 North American Spine Society Annual Meeting. While average Neck Disability scores and improvement were similar among both patient groups, subsequent surgery rates were significantly lower for Mobi-C (3.8%) compared with ACDF (16.2%) at 60 months. The study also showed that the trials primary endpoint called “Overall Study Success” was significantly better with Mobi-C two-level patients, supporting the notion that this innovative technology has the ability to provide patients with not only an alternative, but a superior treatment to fusion.

Possible Risks/Complications Following Surgery

As with any artificial disc surgery, complications may occur when you are treated with the Mobi-C. Possible complications may include, but are not limited to the following:

• Neck, back, shoulder, and/or arm pain
• Less neck movement than before surgery
• Needing additional neck surgery after disc replacement
• Feeling of pins and needles in the arms (sensory disturbance)
• Difficulty swallowing
• Headache

Mobi-C is intended to be used in adults however the safety and effectiveness of the Mobi-C has not been tested in patients younger than 21 years of age or those older than 67. Mobi-C is indicated to take the place of one or two damaged discs (contiguous or adjacent) from levels C3-C7. Patients should have:

• Tried at least six weeks of other medical treatments such as physical therapy and medicine before having surgery; or
• Have signs or symptoms that their condition is getting worse even with other medical treatments.

For a full list of warnings, precautions, and indications, please visit www.CervicalDisc.com