Ti Synex Vertebral Body Devices (VBRs) Subject of an FDA Class 1 Recall. Those Injured by Failed Devices Can Get Information From Our Lawyers.
The attorneys in Weitz & Luxenberg’s dangerous drug and medical device unit are currently investigating cases of individuals who suffered significant injuries after their Ty Synex vertebral body device device failed. The devices were the subject of a November 2009 Class 1 FDA recall.
if you or a loved one experienced a failure of a Synthes VBR device, please complete the form on this page for more information about your legal options.
In the field of orthopedic surgery, the use of implanted devices to replace a painful or degenerating bone or joint have helped thousands of patients to regain mobility and enjoy normal quality of life.
For those who were seriously injured in an accident or developed serious degenerative vertebral conditions, orthopedic surgeons have utlized vertebral body replacement devices (VBRs) to replace a collapsed, damaged or otherwise unstable vertebral body in the thoracolumbar spine (T1-L5).
Synthes USA, an international medical device company, has designed and marketed surgical and orthopedic medical devices for over 25 years. In June 2007, the company began to manufacture their Ti Synex II VBR devices.
Problems with Ti Synex VBRs
As part of the company's oversight of their products, Synthes evaluated adverse event reports submitted to the FDA by physicians and healthcare providers whose patients had experienced problems with the Ti Synex VBR devices.
In the two years the devices had been marketed, six adverse event reports were reviewed. In these cases, patients experienced failures of the central body component between six to fifteen months after having the VBR implanted. Depending on the severity of the failure, these patients developed moderate to severe loss of vertebral body replacement height.
As a result of the adverse event reports, the company issued a global voluntary recall of all the Ti Synex II VBR devices.Injuries Caused by VBR Device Failures
Symptoms that a Ti Synex II VBR device could be failing include increased pain, spinal kyphosis (a form of curvature of the spine), nerve injuries, spinal compression fractures and fixation failures.
In cases where a VBR device fails, patients may have to undergo additional surgical procedures in order to correct the VBR device problems.
Contact Our Lawyers for a Free Case Review
If you or a loved one has suffered an injury caused by the implantation of a TI Synex vertebral body replacement (VBR), our lawyers may be able to help you to seek compensation for your injuries, pain and suffering and other financial compensation.
Please complete the form on this page for a free review of your potential lawsuit. A Weitz & Luxenberg representative will contact you as soon as possible.
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