Synex II Spinal Implant Recalled

In September, the device company Synthes USA recalled the Synex II Vertebral Body Replacement device, a titanium implant used to replace an unstable or damaged vertebral body in the T1 to L5 portion of the spine.

The devices were recalled after the company received six reports in which the device collapsed in patients who had their implants from six to 15 months. After a collapse, patients could experience neural injury, increased pain, spinal compression fracture, failure of additional fixation, and a need for revision surgery.

Surgeons and hospitals that have the Synex II devices should stop implanting them and contact the company for instructions on how to return them. The company also says that all patients with these implants should receive annual radiographic exams and pain assessment.

Patients who have already received these implants should be notified about the potential for the implant to collapse. They should be told that these failures could occur with or without a traumatic event, such as an accident or fall, and that if a failure occurs they may or may not experience pain or other symptoms. Patients should be advised to contact their doctor immediately if they do experience symptoms such as leg or back pain, muscle weakness, tingling or numbness.

FDA Patient Safety News: February 2010