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.If information is provided in the future, a supplemental report will be issued.
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It was reported that on: (b)(6) 2007: the patient presented with the following pre-op diagnosis: spondylolisthesis, l4-5.Spondylolisthesis, l5-s1.She underwent the following procedures: l4-5 laminectomy, medial facetectomy and foraminotomy.L5-s1 laminectomy, medial facetectomy and foraminotomy.L4 to the sacrum posterior instrumentation, segmental, with pedicle screws.L4 to the sacrum posterolateral fusion with local autograft and bmp.As per the operative notes, ¿she is brought to the operating room for l4 to the sacrum decompression and fusion with possible interbody graft.Patient understood that we would use bone morphogenic protein and local autograft rather than take bone graft from her hip.The wound was copiously irrigated with antibiotic solution.A 16-gauge catheter was then threaded cephalad through the residual l4 lamina and a combination of 3.5 cc duramorph and 3.5 cc of 0.25% marcaine were injected in the epidural space for postoperative analgesia.Tisseel fibrin glue was then used to achieve hemostasis in the epidural space and seal the epidural space from any errant bone morphogenic protein that might leak towards the canal.Cobb elevators were then u sed to retract the paraspinous muscles lateral to the screw heads and a combination of local autograft from the laminectomy and bmp soaked in compression resistant matrix was placed lateral to the screws and between the transverse process of l4, the transverse process of l5, and the sacral ala bilaterally.¿ no intra-operative complications were reported.Post-operatively, the patient alleged unspecified injury due to the use of rhbmp-2/acs.
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