(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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It was reported that on (b)(6) 2009 the patient underwent the following procedures: l4-5 posterior spinal fusion, posterior lumbar interbody fusion, l4-5, decompression, l4-5, nonsegmantal instrumentation with polyaxial pedicle screws, l4-5, interbody cage, l4-5, local bone graft with rhbmp-2/acs to treat the following pre-op diagnosis: herniated disk, l4-5, left lower extremity radiculopathy.Operative notes: ".As well as rhbmp-2/acs sponge with bone graft bone graft extender.Rhbmp-2/acs sponge was placed into the facet joint on the right as well.On the left side graft was placed lateral to the hardware.Two lordotically contoured rods were applied to the pedicle screws and secured in compression.The cage was directly palpated and found to be stable." the patient was returned to the supine position, awakened, extubated and transferred to the recovery room having tolerated the above procedure well and in stable condition.
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