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.
- 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.
Your medical history is very important in your doctor’s decision to choose the Mobi-C for you. Before recommending the Mobi-C, your doctor will take into account your past and present health, such as:
- Your job and activity level.
- Past injury or ongoing illness.
- Alcoholism or drug abuse.
- Medicine use.
- Previous treatments.
You may be asked questions to help decide if you have a risk of low bone mineral density. Based on your answers, your doctor may order a bone test (DEXA measurement). The Mobi-C has not been tested in patients with a DEXA T score less than -1.5. This level of DEXA score shows the patient may be osteoporotic or osteopenic.
Your doctor will choose the best Mobi-C size for your body. A correctly sized Mobi-C helps the implants stay in place and work right. Your doctor should not start surgery without the right implant size or instruments in good working order. Ask your doctor to see the full list of risks and complications in the insert.
Your doctor will keep the Mobi-C clean (sterile) and undamaged.
Take care to follow your doctor’s directions. Right after surgery, you should not:
- Do any heavy lifting.
- Bend your neck multiple times.
- Do any long or difficult activity. You may need to limit activity for weeks to months depending on your level of healing.