(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) 2013, patient underwent following procedure, removal of hardware, bilateral l4, l5, s1.Exploration of fusion l4-l5, l5-s1.L3 laminectomy with decompression of canal and nerve roots.Bilateral foraminotomies, l3, l4 with lysis of adhesions at l3-l4 junction.Bilateral l3-l4 facetectomy.Revision posterolateral fusion l4-l5, l5-s1 with extension fusion to l3 using bmp harvest local bone graft and bone marrow aspirate.Aspiration of ilium for bone marrow aspirate to be used in posterolateral fusion mass.Pedicle screw instrumentation, bilateral l4-l5, 7.5 x 45-mm, right s1 8.5 x 30 rom, left s1 10 x 40-mm, crosslink placed between l5 and s1.Pre-op and post-op diagnosis, status post l4-l5, l5-s1 posterolateral fusion with pedicle screw instrumentation.Pseudoarthrosis l4-l5, l5-s1.Per operative notes, ¿.The bony margins were then exposed from the l2-l3 facet, through the l3 pars, and residual transverse process, bilateral l4-l5, as well as the upper portion of the sacral ala in anticipation of revision fusion.The ilium was aspirated for bone marrow to be used in the posterolateral fusion mass consisting of bmp, and harvest local bone graft and bone marrow aspirate.She was transferred to the recovery room in stable hemodynamic and neurologic condition." post-operatively the patient was diagnosed with stenosis and non union due to which the patient underwent revision surgery.On (b)(6) 2013, patient underwent following procedure: incision and drainage of lumbar wound.Pre-op and post-op diagnosis: lumbar wound infection.No complications were reported.
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