(b)(4).Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.Multiple products were implanted 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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It was reported that on (b)(6) 2014, the patient underwent multi-level fusion surgery ,using rhbmp-2, in the state of coma and was not aware of the details regarding the device.Post-op, the patient had been feeling paralyzed.The patient complained of nerve damage, anxiety, pain, numbness and permanent injuries.He stated that he had been on steroids, epidural injections, and watson pill for past three years.The patient still experienced these symptoms.
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