Possible Complications

Complications may occur when you are treated with the Mobi-C, as with any surgery. Possible complications may include, but are not limited to the following.

Risks from any surgery:

• Problems with the wound healing including pain.
• An allergic attack or infection.
• Problems with the heart (cardiovascular) or blood movement (circulation). This could include: loss of blood, a reaction to a blood transfusion, problems with circulation, or problems with blood forming into clumps (clotting).
• A sickness to the drugs used to put you asleep during surgery (anesthesia).
• Problems with the stomach and intestines (gastrointestinal).
• Problems with the urinary or genital systems (urogenital).
• Problems breathing (respiratory). Respiratory problems could include: lung infection (pneumonia), lung tissue collapsing (atelectasis), or swelling in the neck (edema).
• In rare situations, heart attack, stroke, or death.

Risks from anterior cervical spine surgery:

• Infection, swelling, and problems healing at or anywhere near the surgery site. This could affect, for example, the blood vessels, nerves, spinal cord, trachea, esophagus, disc, vertebrae, and skin.
• Neck and/or arm pain.
• Headaches: weak to strong.
• Pain or damage to the organ that allows you to talk (dysphonia).
• Pain or damage to the muscles that allow swallowing (dysphagia).
• Problems with feeling, movement, or response time (neurological issues) in the upper arm, neck, back, leg, or other area.
• In rare situations, loss of movement (paralysis).

Risks specific to cervical artificial discs including the Mobi-C:

• Less neck movement than before surgery due to:
  • Stiff ligaments (spinal ligament ossification).
  • An overgrowth of bone (heterotopic calcification) at the surgery level.
  • Vertebrae fusing together.
• The implant breaking, moving, or wearing.
• Needing additional neck surgery after disc replacement.
• The development of a recurrent spinal problem at the surgery level, as well as the development of a new spinal problem above or below the treated spinal levels.

There is also the risk that the surgery may not be effective in relieving your symptoms or may cause worsening of your symptoms. If this occurs, you may need another surgery in order to help you feel better.

Throughout the Food and Drug Administration (FDA) clinical study, patients reported health related problems to their doctors.

Some important one-level study events through 5 years after surgery for the Mobi-C and the Anterior Cervical Discectomy and Fusion (ACDF) patients include:

• Neck pain in 52% of Mobi-C patients (93 out of 179 patients) and 53% of ACDF patients (43 out of 81 patients).
• Arm (extremity) pain in 38% of Mobi-C patients (68 out of 179 patients) and 31% of ACDF patients (25 out of 81 patients).
• Combined neck and arm (extremity) pain in 6% of Mobi-C patients (10 out of 179 patients) and 9% of ACDF patients (7 out of 81 patients).
• Back pain in 32% of Mobi-C patients (57 out of 179 patients) and 33% of ACDF patients (27 out of 81 patients).
• Shoulder pain in 29% of Mobi-C patients (51 out of 179 patients) and 27% of ACDF patients (22 out of 81 patients).
• The feeling of pins and needles in the arms (sensory disturbance) in 47% of Mobi-C patients (84 out of 179 patients) and 48% of ACDF patients (39 out of 81 patients).
• Headache in 31% of Mobi-C patients (56 out of 179 patients) and 35% of ACDF patients (28 out of 81 patients).
• Difficulty swallowing (dysphagia) in 12% of Mobi-C patients (21 out of 179 patients) and 20% of ACDF patients (16 out of 81 patients).

Five patients (3%) treated with Mobi-C and nine patients (11%) treated with ACDF had additional surgery at the same level within 5 years after their surgery. Four patients (2%) treated with Mobi-C and nine patients (11%) treated with ACDF, had surgery at an adjacent level within 5 years after surgery. No mechanical failures of the Mobi-C device were observed in any study patients.

A comprehensive list of risks is provided in the package insert for the device, which your doctor has received. Please ask your doctor for more information about any additional risks that could be related to your planned surgery.

Some important two-level study events through 5 years after surgery for the Mobi-C and the Anterior Cervical Discectomy and Fusion (ACDF) patients include:

• Neck pain in 39% of Mobi-C patients (90 out of 234 patients) and 57% of ACDF patients (60 out of 105 patients).
• Arm (extremity) pain in 23% of Mobi-C patients (54 out of 234 patients) and 30% of ACDF patients (31 out of 105 patients).
• Combined neck and arm (extremity) pain in 5% of Mobi-C patients (12 out of 234 patients) and 8% of ACDF patients (8 out of 105 patients).
• Back pain in 32% of Mobi-C patients (76 out of 234 patients) and 30% of ACDF patients (31 out of 105 patients).
• Shoulder pain in 27% of Mobi-C patients (64 out of 234 patients) and 41% of ACDF patients (43 out of 105 patients).
• The feeling of pins and needles in the arms (sensory disturbance) in 41% of Mobi-C patients (96 out of 234 patients) and 52% of ACDF patients (55 out of 105 patients).
• Difficulty swallowing (dysphagia) in 15% of Mobi-C patients (36 out of 234 patients) and 23% of ACDF patients (24 out of 105 patients).
• Headache in 25% of Mobi-C patients (58 out of 234 patients) and 25% of ACDF patients (26 out of 105 patients).

Nine patients (4%) treated with Mobi-C and 17 patients (16%) treated with ACDF had additional surgery at the same level within 5 years after their surgery. Seven patients (3%) treated with Mobi-C and twelve patients (11%) treated with ACDF, had surgery at an adjacent level within 5 years after surgery. No mechanical failures of the Mobi-C device were observed in any study patients.

A comprehensive list of risks is provided in the package insert for the device, which your doctor has received. Please ask your doctor for more information about any additional risks that could be related to your planned surgery.