Mobi-C FAQ



How many degrees of motion does Mobi-C have?

In what direction does Mobi-C allow motion?

 

The Mobi-C has three parts: two metal plates and a medical grade polyethylene insert in the middle. The top plate rotates over the domed insert.

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The insert slides across the bottom plate, left-to-right and front-to-back up to 1mm in any direction. The insert also twists over the bottom plate. The two tabs on the bottom plate provide a safety stop designed to control movement and keep the insert in place.

With vertebra and muscle movement, the Mobi-C is free to bend left-to-right (10° in each direction) and front-to-back (10° in each direction), as well as rotate.


Can Mobi-C be used in an MRI scanner?

 

Yes, under certain conditions a patient with a Mobi-C can be safely scanned in an MRI system. For more information on the scan conditions, please refer your health care professional to the MRI safety information in the Mobi-C Instructions for Use.


Can I receive a Mobi-C if I have a nickel allergy?

 

The Mobi-C Cervical Disc should not be implanted in patients with known allergy to sensitivity to the implant materials (cobalt, chromium, molybdenum, titanium, hydroxyapatite, or polyethylene). Cobalt chrome alloy, in general, may contain trace amounts of nickel – up to 1.0% by mass.


I have had a previous cervical fusion; can I still get a Mobi-C at a different level?

 

Patients with prior cervical fusion at any level were not studied in the Mobi-C clinical trial. The Instructions for Use approved by the FDA include prior cervical surgery as a precaution. Please consult with Dr. Hale about the use of Mobi-C in this situation.


Can Mobi-C be used in the lumbar spine?

 

No. Mobi-C is only indicated for use in the cervical spine at one or two adjacent levels for levels C3-C7.


Can Mobi-C be used at more than two levels in the cervical spine?

 

Mobi-C is only indicated for use in the cervical spine at one or two adjacent levels for levels C3-C7.


Is Mobi-C considered experimental?

 

No, Mobi-C is not considered experimental. In 2013, Mobi-C was approved for use in the U.S. by the Food and Drug Administration (FDA). Mobi-C has been successfully used in hundreds of U.S. hospitals and in thousands of U.S. patients to date, and over 70,000 global implantations.

To gain approval, Mobi-C underwent a rigorous prospective, randomized, multi-center clinical study. You can find Mobi-C’s letters of approval on the FDA’s website, at the following links:


Is there data available regarding the life expectancy of Mobi-C?

 

Before being implanted in people, Mobi-C was tested in a lab. One industry standard test looked at implant wear. The wear test measured Mobi-C’s medical grade polyethylene insert for changes to size and weight after movement. To mimic the natural motion of the neck, the test used the combined movements of:

  • Side bending (lateral bend).
  • Forward-to-back bending (flexion-extension).
  • Turning left-to-right (rotation).
Every Mobi-C tested in the lab completed 10 million movement cycles, all demonstrating low wear rates.

During this testing there were:
  • No mechanical failures.
  • No significant damage to the polyethylene insert or the metal plates.
  • No major biomechanical issues.
  • Mobi-C was then implanted and studied in patients. The testing data and two years of patient clinical data were reviewed by the FDA as part of the Mobi-C approval process in the U.S.

Zimmer Biomet, the manufacturer of Mobi-C, cannot predict the Mobi-C life expectancy for each patient. However, Mobi-C has been implanted over 70,000 times, in the U.S. since 2006 and in Europe since 2004.


What happens during Mobi-C surgery?

 

The surgical approach and preparation are largely the same for Mobi-C and fusion surgery.

In the operating room:

  • You will lie on your back on a table and be put into deep sleep (anesthesia). Once asleep, your neck area is washed.
  • A clean (sterile) sheet is taped around your neck.
  • A cut (incision) is made on your neck. We will move the muscles, the airway (trachea), the esophagus, and blood vessels to the side. This makes a tunnel to the spine.
  • Using a special X-ray (fluoroscopy), we will pass a thin needle into the damaged discs to check the levels for surgery.
  • We will remove the damaged discs and put in Mobi-C. Fluoroscopy may be taken during surgery to check Mobi-C placement.
  • The muscle and skin incisions will be sewn together with surgical thread (sutures). A small bandage or biologic glue will be placed across the incision.

Immediately after surgery:

  • While asleep, you will be moved to a new area (Recovery Room
  • Nurses will check your blood pressure, heart rate, and breathing
  • If you are in pain, you may be given medicine.
  • Once awake, you will be moved to a different room.


What will my surgery cut (incision) look like?

 

The cut will likely be a short incision in the front (anterior) part of the neck. The cut is usually made in a line you already have in the skin on your neck and generally heals so that it is difficult to see.


When can I drive after Mobi-C surgery?

 

The timing varies from patient to patient.


Will my Mobi-C affect travel through airport security?

 

It is very unlikely that the metal in the Mobi-C will set off airport security detectors. However, the Transportation Security Administration (TSA) rules state, “TSA Security Officers will need to resolve all alarms associated with metal implants.”


What are the instructions for activity limitations after my procedure?

 

Typical instructions following a Mobi-C surgery include avoiding heavy lifting, repetitive bending, and prolonged or strenuous activity for a period of weeks to months depending on the post-operative process.


When can I return to work?

 

Returning to work after Mobi-C cervical disc replacement depends on your own recovery process. Most patients return to work within six weeks of surgery.

In the U.S. Mobi-C clinical trial, the return to work time was 20.9 days shorter for Mobi-C patients compared to fusion patients for two-level surgery and 7.5 days shorter for Mobi-C patients compared to fusion for one-level surgery.