Who Should Receive a Mobi-C?

• Is for adults; the vertebrae must be mature (age range, 21-67 years) and takes the place of one or two damaged cervical discs next to each other (contiguous or adjacent) 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 boney growth (osteophytes) on a vertebra.
  • Loss of disc height 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 the 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).

The safety and effectiveness of the Mobi-C has not been tested in patients with the following conditions:

• The young (younger than 21) and the elderly (older than 67).
• Previous cervical spine surgery, including a repeat surgery at the same levels.
• More than two cervical spine levels that are damaged or stopped moving that need surgery.
• Short disc height, defined as a disc height less than:
  • 3mm measured from the center of the disc.
  • One-fifth of the front-to-back measurement of the lower vertebra.
• An unhealthy curving of the cervical spine (kyphosis or reversal of lordosis).
• Active cancer (malignancy).
• Diseases of the bone caused by low mineral levels or genetic problems (Paget’s disease, osteomalacia, or other metabolic bone diseases).
• Taking medicine that is known to get in the way of bone or soft tissue healing, such as steroids.
• Pregnancy.
• Diabetes that needs medicine (insulin) given every day.
• Very overweight (obese) (based on the NIH Clinical Guidelines Body Mass Index (BMI greater than 40)).
• Neck or arm pain from an unknown source.
• Whole body (systemic) diseases, including AIDS, HIV, and hepatitis.
• Findings which suggest an irritated nerve root (radiculopathy) or spinal cord (myelopathy) where there is a poor match between the image
• findings (CT, MRI, or X-ray) and the physical examination.
• A previous fusion at a level above or below the surgery levels.
• Only neck pain with no arm pain.
• Diseases that cause the vertebrae to swell or grow together and limit movement, such as rheumatoid arthritis or other autoimmune diseases.
• Diseases that affect muscle movement because of problems with the nerves or muscles (neuromuscular disorders). Disease examples include:
• muscular dystrophy, spinal muscular atrophy, and amyotrophic lateral sclerosis.
• Serious mental illness or drug abuse.