(b)(6) medical center, (b)(6): (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.If information is provided in the future, a supplemental report will be issued.
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It was reported that on: (b)(6) 2010: the patient presented with the following pre-op diagnosis: l3-4 and l4-5 disc protrusion with annular tears and underwent the following procedures: l3-4 and l4-5 anterior lumbar interbody fusion via direct lateral approach, endoscopically assisted.Placement of carbon fiber fusion cages at l3-4, l4-5.Placement of bone morphogenic protein(bmp).As per operative notes,¿ the annulotomy, discectomy ,endplate preparation was done, shaping and fitting of the disc space to a size 10 non-lordosed (parallel) 55 mm cage was done and placed at l3-4 that was prefilled with the bmp and was secured with absorbable 2-0 vicryl suture.Similarly, procedure was performed at l4-5.X-rays revealed quite good cage placement at both levels." no intra-operative complications were reported.Post-op, the patient complained of increasingly severe pain in his low back with radiculopathy, weakness, numbness, tingling and burning into his legs.It was reported that the patient experienced severe and unrelenting low back pain and swelling, numbness and tingling from his back down into his hips and legs, and burning in his calves, as well as difficulty in standing and walking.
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