AR: In September, the device company Synthes recalled the Synex II Vertebral Body Replacement device. This is a titanium implant used to replace an unstable or damaged vertebral body in the T1-to-L5 portion of the spine.
MB: The devices were recalled after the company received six reports in which the device collapsed in patients who had their implants from 6 to 15 months. After a collapse, patients could experience neural injury, increased pain, spinal compression fracture, failure of additional fixation, and the need for revision surgery.
AR: 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.
MB: Patients who've 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 a 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.

标题
Synex II Spinal Implant Recalled (FDA)

视频介绍
FDA Patient Safety News - February, 2010 - Show #95
In September, the device company Synthes recalled the Synex II Vertebral Body Replacement device.