It was reported that the patient underwent a posterior lumbar interbody fusion of l3-4 and l4-5 with insertion of fusion cages at l3-4 and l4-5, and rhbmp-2/acs.Reportedly, imaging studies, at unspecified time, showed that the patient developed uncontrolled bone growth and resulting nerve com pression at or near the implant site.Reportedly, the patient suffered from chronic pain, emotional distress and mental anguish, disability and disfigurement.The patient died ten months after surgery.Cause of death was not reported.
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(b)(4).Neither the device nor applicable imaging study films or patient medical records were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Products from multiple manufacturers were implanted/used during the procedure.Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes.
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