It was reported that the patient underwent a l4-s1 tlif and posterolateral lumbar fusion surgery in which rhbmp-2/acs was used.Reportedly, following the procedure, the patient continued to experience severe back pain.Approximately 39 months post-op, the patient was diagnosed with excessive bone growth encasing his l4 and l5 spinous processes and within the l5-s1 interspace of his spine.The patient continued to experience severe pain and underwent a surgical revision.Reportedly, the patient continued to have daily, severe, disabling pain.
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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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