Defective Products Law Practice

 - Vertebral Body Replacement Investigation -

Our law firm is investigating defects in Synthes vertebral body replacement (VBR) implants.  We are accepting selected cases in this area.

The Food and Drug Administration (FDA) has announced a Class 1 recall of Synthes USA, Ti Synex II VBR medical devices. A Class 1 recall is the most serious type of recall and and is issued when there is a reasonable probability that use of the recalled products will cause adverse health consequences or death.

Vertebral body replacement is performed 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 VBR 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.”

Complaints collected by the FDA, however, allege moderate to severe loss of vertebral body replacement height caused by failure of the device's central body component. A press release issued by the device manufacturer reports six patient injury events. 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.”

Patients implanted with the recalled VBR components may be at risk. The recalled vertebral body replacement implants were manufactured from June 8, 2007, through September 9, 2009, and distributed from July 2, 2007, through September 8, 2009.

Personal injury caused by defective design, manufacturing defect, or failure to equip a medical device with warnings of a personal injury risk may support a lawsuit to recover medical costs, pain, lost wages, and other compensation. If you or a loved one believe that you may have sustained injury due to a defective VBR or other medical device, an experienced product liability lawyer at the Portland, Oregon personal injury law firm of Vangelisti Kocher LLP can answer your medical device injury questions in a free, confidential consultation.

Please contact us by email, or call Jamie Telegin at our office at (503) 445-2102, or toll free at 1 (800) 800-1004.

   Scott F. Kocher, J.D. Harvard Law School

   Lead investigating attorney
 

   Vangelisti Kocher LLP

   811 SW Naito Parkway, Suite 420

   Portland, OR 97204

   503-445-2100