It was reported that on an unknown date in (b)(6) 2011, the patient presented with pain in her spine.Doctor recommended two surgeries to correct her pain.On (b)(6) 2011, the doctor performed surgery on patient, consisting of a lumbar spinal fusion with implanted hardware in which rhbmp-2/acs was used.On (b)(6) 2011, doctor performed surgery on patient, consisting of a disectomy and fusion of the thoracic spine using rhbmp-2/acs with the installation of hardware.Patient continued to receive post-operative treatment.Patient continued to suffer from back pain after this surgery, and she has been forced to deal with constant discomfort and pain from her implanted hardware.Patient is unable to stand or walk for more than 20 minutes at a time.
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(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.Products from multiple manufacturers 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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