The Food and Drug Administration has announced a Class 1 recall of Synthes USA, Ti Synex II Vertebral Body Replacement (VBR) medical devices. Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause adverse health consequences or death.
The Law Office of Dane E. Johnson is currently investigating injuries arising out of Synthes vertebral body replacements. If you or a loved one have reason to believe that a VBR implant has caused serious personal injury, we offer a free attorney consultation and case evaluation to discuss your legal rights. Experience and education allow us to evaluate medical injuries effectively and pursue products liability claims vigorously on behalf of those injured by defective medical devices.
VBR devices are intended for use in the thoracic and lumbar spine to replace collapsed, damaged, or unstable vertebral bodies due to tumors or trauma, such as fractures. Synthes describes the recalled implant as “an expandable vertebral body replacement device that is available in several heights and various endplate configurations. The self-locking implant provides an efficient means of restoring proper spinal alignment using rapid and controlled in situ expansion with minimal instrumentation.”
Loss of device height in the recalled Synthes medical devices, however, may result in nerve injury, increased pain, spinal compression fracture, failure of additional fixation, and/or need for a reoperation or an operation to modify the implanted device. A Synthes press release reports six patient injury events involving Synex II Central Body Components. Injuries included moderate to severe loss of vertebral body replacement height caused by failure of the central body component. According to the company, “potential adverse health issues that could be associated with this issue include neural injury, increased pain, spinal kyphosis if unrecognized, failure of supplementary fixation, and/or need for reoperation/revision surgery.”
The recalled products were manufactured from June 8, 2007, through September 9, 2009, and distributed from July 2, 2007, through September 8, 2009. Patients who have already undergone VBR implantation may be at risk. Those who have sustained spine injury or are forced to undergo repeat surgeries may have products liability claims for medical costs, pain, lost wages, and other compensation.
Please submit our online form or call us toll free at (800) 714-3204. If you need immediate assistance with a legal question involving any medical device, call Portland, Oregon personal injury lawyer Dane Johnson directly at (503) 975-8298.
Related Web Resources
FDA Medical Device Recalls, Synthes USA, Ti Synex II Vertebral Body Replacement (VBR) (Nov. 13, 2009).
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