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) 2009: the patient presented with the following pre-op diagnosis: spinal stenosis.Disk herniation with spondylolisthesis.She underwent the following procedures: l2-3, l3-4, l4-5 and l5-s1 decompressive laminectomy with l4-5 diskectomy.Interbody fusion utilizing peek implants with l2-s1 pedicle screw fixation.Posterolateral fusion.As per the operative notes, ¿we prepared the disk for the interbody fusion.We ended up placing a 15mm peek graft packed with bmp and patient bone.This was countersunk with good fixation and fusion.We placed one graft bilaterally.We then placed these into compression and tightened the nuts across the rods which were placed across the l2, l3, l4, l5 and s1 screws.We obtained an x-ray confirming good placement of the screws and rods as well as the interbody fusion.We decorticated posterolaterally and did a fusion at l2-3, l3-4, l4-5 and l5-s1.We did this with bmp, demineralized bone matrix mixed with patient¿s bone as well as putty." 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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