Ti Synex II Vertebral Body Replacement May Result in Adverse Health Issues

October 11, 2013

Important Information

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At A Glance

This Alert Affects
Patients who experienced adverse side effects, including increased pain, neural injury and spinal compression fracture, after being implanted with the Ti Synex II Vertebral Body Replacement.
Damages
The Ti Synex II Vertebral Body Replacement can cause increased pain, neural injury, failure of additional fixation, spinal compression fracture or the need for an additional operation to fix the device.
Company(ies)
Synthes USA
Additional Details
The Ti Synex II Vertebral Body Replacement is used to replace a collapsed, unstable or damaged vertebral body in the spine.
Date
The Ti Synex II Vertebral Body Replacement was issued a class I recall on Sept. 14, 2009.