FDA Recall of Ti Synex II Vertebral Body Replacement
by Marc Stern on Dec.01, 2009
We are currently investigating the FDA’s Class I Recall of the Ti Synex II Vertebral Body Replacement device manufactured by Synthes USA.
The implantable device is used in the T1-L5 portion of the spine to replace a collapsed, damaged, or unstable vertebral body. Failure of the central body component resulting in loss of vertebral body replacement height has been reported in some patients.
Potential adverse health effects linked to device failure include nerve injury, increased pain, spinal compression fracture, failure of supplementary fixation, and/or the need for revision surgery. If you’re interested in working with us on this case type, please drop me a note.
One comment to “FDA Recall of Ti Synex II Vertebral Body Replacement”
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January 18th, 2010 on 7:28 pm
I fell from a ladder onto my driveway and crushed by L3 and L4 vertebrae. I had surgury May 14 the Ti Synex II was inserted in my spine.