It was reported that the patient underwent removal of left side l4, l5, and s1 hardware with exploration of fusion mass under fluoroscopic guidance, utilizing rhbmp-2/acs.It is unclear as to whether an lt cage was or was not used during surgery, as the use of the lt cage has been reported both ways to the manufacturer.Reportedly, the patient¿s pain and difficulties did not subside.The patient suffers from ectopic bone growth, chronic pain syndrome, low back and buttock pain, leg pain, deterioration of the spine, bulging discs, anxiety, depression, and narcotic dependence from prescribed painkillers.
|
(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.
|