Frequently Asked Questions

As coverage varies state-to-state and payer-to-payer, we recommend that you direct questions regarding insurance coverage to the billing department of your surgeon's or hospital's office. Additionally, directly contacting your insurance company and/or your Human Resources department is another way to better understand your policy.

ZimVie provides reimbursement support through our Reimbursement Hotline. For more information, visit the Insurance Coverage page or contact a Reimbursement Specialist toll-free at 877-331-0062 (Monday - Friday 8AM - 5PM Eastern) or email Mobi-C@mcra.com.

ZimVie is dedicated to expanding patient access to Mobi-C. The appeals process allows health plans to review denials in accordance with their medical policies and clinical guidelines. We encourage you to review your case with our Reimbursement Specialists at 877-331-0062 or email Mobi-C@mcra.com in order to determine if ZimVie can help you with your appeals process.

Ask your doctor to describe how you will feel and what you will need to do to recover from cervical disc replacement surgery. Anterior cervical spine surgery is a major surgery. Getting better will take time. How fast you get better depends on your age, your general health, and the reason for the surgery. Your doctor may recommend exercise with the help of a physical therapist. As with any surgery, it is extremely important to follow your doctor’s direction after surgery. Here are some examples of directions to follow after surgery. Your doctor’s directions may be different.

• Stay one night in the hospital.
• Sit, stand, and walk the night after surgery.
• Wear a neck collar to lessen neck movement for around a week after the surgery.
• Take medicine (by mouth) for pain or sickness of the stomach (nausea) as needed.
• Put a new, clean bandage on the cut five days after surgery. The doctor or nurse may show you how to change the bandage.
• Set up a time to visit your doctor to check your healing. Your doctor may take X-rays to look at the Mobi-C placement in your neck.
• Get direction from your doctor on when it is OK to return to your normal neck bending and turning. Talk to your doctor about a physical therapy plan.

Ask your doctor to describe how you will feel after surgery. Some pain and discomfort is normal. The problems you had before surgery may not lessen right away. Talk to your doctor about when to call with problems after surgery. If you have any of these problems at any point after surgery, call your doctor.

• Signs that your cut (incision) may not be healing (infection):
  • The incision is draining. Although, you can expect some wetness.
  • The skin around the incision becomes red, warm, swollen, or increasingly painful.
  • You have a fever.
  • Pain or problems with swallowing (dysphagia), talking (dysphonia), or breathing. It is common to experience some mild, temporary discomfort with swallowing.
  • More tingling, numbness, pain, or weakness in the arms or neck than you had before surgery.

Mobi-C was:

• Designed by an experienced European surgeon team
• First implanted in November 2004 in Europe
• Entered into an FDA Investigational Device Exemption (IDE) study for one and two-levels in 2006
• FDA approved for use at both one and two-levels in the United States in August 2013

Over 150,000 Mobi-C Discs have been implanted in 25 countries since 2004.

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
• 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.

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.

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.

Only trained surgeons that are actively implanting Mobi-C are listed on the surgeon finder at www.cervicaldisc.com/surgeon-locator. The FDA requires surgeons to complete training before implanting Mobi-C. The training includes detailed lectures on product design, surgical technique, and Mobi-C study data. Training also includes hands-on experience with the instruments and implants, which for many surgeons was conducted in a bioskills lab.

The surgeon finder is a free service, helping patients to find qualified surgeons. Since surgeons must choose to be included in the surgeon finder, the surgeon finder list on www.cervicaldisc.com/surgeon-locator may not represent the complete list of all trained Mobi-C surgeons. You should inquire directly with your surgeon about their Mobi-C training status and surgical experience.

ZimVie is dedicated to expanding patient access to Mobi-C. The appeals process allows health plans to review denials in accordance with their medical policies and clinical guidelines. We encourage you to review your case with our Reimbursement Specialists at 1-866-946-0444 or email reimbursement@ZimVie.com in order to determine if ZimVie can help you with your appeals process.

Every surgeon on the locater has attended a Mobi-C training, which includes detailed lectures on product design, surgical technique, and Mobi-C study data. Training also includes hands-on practice with the instruments, which for many surgeons was conducted in a bioskills lab.

Patients should ask their surgeon about their Mobi-C surgical experience.

Talk to your doctor to see if Mobi-C is a viable option in treating your symptoms. The Mobi-C Cervical Disc:

• Is for adults; the vertebrae must be mature (age range, 21-67 years).
• Takes the place of one or two adjacent damaged cervical disc(s) from levels C3-C7.
• Is for patients with arm pain and/or neurological symptoms such as weakness or numbness with or without neck pain. The damaged disc may be irritating the:
  • Spinal cord (myelopathy) or nerve roots (radiculopathy). This can cause a loss of feeling, loss of movement, pain, weakness, or tingling down the arm and possibly into the hands.
• Disc damage needs to be proven by your doctor’s review of your CT, MRI, or X-ray images. Images of the neck should show at least one of the following:
  • Inner disc squeezing through the outer disc (herniated nucleus pulposus).
  • Degeneration of the spine from wear and tear (spondylosis). There may be bony growth (osteophytes) on a vertebra.
  • Loss of disc height at the affected level(s) compared to the levels above and below.
• Is for people who have not responded to non-surgical care. Patient should either 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.

If you have any of the following, you should NOT have surgery with Mobi-C:

• An active whole body (systemic) infection, such as pneumonia.
• An infection at the surgery site, such as a skin rash or infected cut.
• A known allergy to what Mobi-C is made of: cobalt, chromium, molybdenum, titanium, hydroxyapatite, polyethylene, and other trace elements. Talk to your doctor if you have a metal allergy.
• Damaged cervical vertebrae from an accident (trauma) at one of the surgery levels.
• An unhealthy shape (deformity) of the cervical vertebrae at one of the surgery levels. Deformity could be caused by an inflammatory disease where the vertebrae swell or grow together and limit movement, such as ankylosing spondylitis and rheumatoid arthritis.
• A cervical spine that shows an unhealthy amount of extra movement (instability). This can be measured by X-rays taken from your side when the spine is still and bending.
• Low bone mineral density, such as osteoporosis or osteopenia (defined as a DEXA bone mineral density T-score < -1.5). This condition could increase the risk of bone breaking or cause an implant to loosen.
• Severe disease or degeneration in the joints in the back of the cervical vertebrae (facet joints).

Please see the “Am I a Candidate” section of CervicalDisc.com to see if you qualify.

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 your surgeon about the use of Mobi-C in this situation.

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

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

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:

• Mobi-C One-level FDA approval letter
• Mobi-C Two-level FDA approval letter

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.

ZimVie 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.

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. Your doctor 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), your doctor will pass a thin needle into the damaged discs to check the levels for surgery.
• Your doctor 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.

Before artificial discs, such as Mobi-C, most often a patient would get an anterior cervical discectomy and fusion (ACDF). Both a fusion and a disc replacement surgery occur from the front of the neck and have similar operative steps. In both surgeries, the doctor removes the unhealthy disc. The empty disc space is filled with the chosen implant. The implant helps match the disc height to the levels above and below. Restoring the disc height can help remove pressure on the nerves and/or spinal cord.

Only in a fusion surgery:

• A bone spacer or plastic implant is placed between the bones of the neck (vertebrae) to replace the removed disc
• Often a plate is installed over the front of the vertebrae to help keep the spacer in place
• The plate and spacer are used to stop movement at that level. This helps new bone grow between the vertebrae (fusion)

Only in a Mobi-C surgery:

• A mobile bearing disc replacement is placed between the vertebrae to try and maintain normal neck movement
• A Mobi-C disc fits entirely within the disc space with no keels or screws needed to secure the disc

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

You will need to keep your incision dry immediately after surgery. Some doctors allow early showering. Patients normally take baths for 1-2 weeks after surgery. Get direction from your doctor on when it is OK to start showering.

Ask your doctor when you can start driving after surgery. The timing varies from patient to patient.

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.”

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 and instructions from your surgeon.

Returning to work after Mobi-C cervical disc replacement depends on your doctor's advice and 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.