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.
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.
The Ti Synex II Vertebral Body Replacement is used to replace a collapsed, unstable or damaged vertebral body in the spine.
The Ti Synex II Vertebral Body Replacement was issued a class I recall on Sept. 14, 2009.
In Sept. 2009, the FDA issued a class I recall on all lots of the Ti Synex II Vertebral Body Replacement, which is a device used to replace a collapsed, damaged or unstable vertebral body in the spine. Made by Synthes USA, the Ti Synex II Vertebral Body Replacement has reportedly caused moderate to severe loss of vertebral body replacement height, which can lead to adverse health issues.
The loss of vertebral body replacement height has reportedly been caused by failure of the central body component. Patients experiencing Synex Vertebral Body Replacement side effects related to vertebral body replacement height loss have reported the following complications approximately six to 15 months after implantation:
Spinal compression fracture
Failure of additional fixation
Need for an operation to fix the implanted device
The recall for the Ti Synex II Vertebral Body Replacement involves part numbers 04.808.001 through 04.808.011, Synex II Central Body, Titanium. These products were made between June 8, 2007 and Sept. 9, 2009 and were shipped from July 2, 2007 to Sept. 8, 2009.
Hospitals and surgeons in possession of the vertebral body replacement were advised to stop implanting the devices as soon as the recall was issued. The FDA’s most severe type of recall, a class I recall means that the device can potentially cause serious injury or death.
Our lawyers believe the manufacturer of the Vertebral Body Replacement did not adequately warn patients of the adverse side effects of the device. Therefore, patients injured by the Ti Synex II Vertebral Body Replacement may be eligible for compensation. To find out if you qualify for a vertebral body replacement lawsuit, fill out the form above.