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It was reported that on (b)(6) 2009: the patient underwent x-rays at ap, lateral, flexion/extension of the lumbosacral spine which showed that the patient had 5 lumbar type vertebral bodies.The hips and si joints appear normal.There were no gross fractures of dislocations.The patient had a grade 1 to 2 anterior listhesis of l5 on s1.It appeared that the listhesis does mildly reduce with flexion and there was disc space narrowing at the l5-s1 level.The other disc spaces appeared to be intact.On (b)(6) 2009: the patient underwent mri of the lumbar spine due to back pain, spondylolisthesis, left buttock and thigh pain with left leg weakness.Impression: grade 1 isthmic spondylolisthesis of l5 on s1 with moderate-to-severe bilateral l5-s1 foraminal stenosis.On (b)(6) 2009: the patient underwent lumbar transforaminal epidural procedure due to continued low back pain and left leg pain.The patient tolerated the procedure well without immediate complication.The patient was monitored for an appropriate period following the procedure.On (b)(6) 2009: the patient underwent lumbar transforaminal epidural procedure due to continued low back pain and left leg pain.The patient tolerated the procedure well without immediate complication.The patient was monitored for an appropriate period following the procedure.On (b)(6) 2009: the patient underwent x-rays which showed that the patient had a grade 1 spinal listhesis at l5-sl with pars defects.Corresponding mrl was reviewed which showed that the patient had disc degeneration at this level with foraminal stenosis left greater than right and a grade 1 spondylolisthesis.On (b)(6) 2009: the patient presented with a pre-operative diagnosis of l5-s1 spondylolisthesis and l5-s1 spinal stenosis with lumbar ra diculopathy due to which the patient underwent the following procedures.Posterior spinal fusion l5-s1.Transforaminal lumbar interbody fusion, l5-s1.Laminectomy with decompression of bilateral l5 nerve roots, l5-s1.Posterior instrumentation l5-s1.Stealth guidance for placement of pedicle screws, l5-s1.Use of local bone graft 7.Use of allograft including bone morphogenic protein.During the surgery a peek concorde bullet and expedium from depuy was also used.On (b)(6) 2009: the patient presented with a post-operative spine wound infection and underwent an incision and drainage of wound down to bone and subfascial procedure.Complications: the patient had to be readmitted after having a posterior lumbar fusion for wound infection and eventually underwent irrigation and debridement.On (b)(6) 2009: the patient underwent x-rays for follow up after posterior lumbar spine fusion and transforaminal lumbar interbody fusion ls-s1 on (b)(6) 2009.The x-rays showed that the patient was starting to have some consolidation present in his disc space at the l5-s1 area.His interbody cage has extruded out approximately about 3 mm or so from the last time.Fortunately this was going at an oblique angle so it was not in the canal.On (b)(6) 2009: the patient underwent x-rays, which showed that the interbody cage was extruded but there had been no change since interval x-rays.The hardware was in appropriate position.On (b)(6) 2009: the patient underwent a ct scan of the lumbar spine due to history of previous infection and leg pain.Impression: postoperative changes of discectomy and fusion at l5-s1.There has been migration of the disc space cage into the left margin of the foramen.Correlation with a left l5 radiculopathy.Approximately half the cage is outside the boundaries of the disc space.Grade 1 anterior spondylolisthesis of l5 on s1 without complication of the hardware.On (b)(6) 2009: the patient presented with a pre-operative diagnosis of left l5 lumbar radiculopathy/radiculitis , pseudoarthrosis l5-s1 and extrusion of interbody cage l5-s1.The radiographs obtained demonstrated that the interbody cage at l5-s1 had backed out.Subsequent ct scan showed that the fusion had failed to take in the interbody space, as well as in the posterolateral gutters.Therefore, the decision was made to have surgery to remove the loosened cage which was pressing on the l5 nerve root.Operation: revision posterior spinal fusion, l5-s1.Revision transforaminal lumbar interbody fusion.Exploration of fusion mass, l5-s1.Reinsertion of spinal fixation devices including rods and set screws.Structural allograft, l5-s1 interbody spacer.6.Use of cancellous chips with bone morphogenetic protein.During the surgery a depuy expedium was used.There were no noted complications.On (b)(6) 2010: the patient presented with a pre and post-operative diagnosis of infected back wound was admitted with low back pain, lumbar incisional pain, irritation and drainage.The patient underwent a debridement and flap closure of back wound procedure due to non-healing wound on his back.Operation: incision and drainage of lumbar wound.Pulsavac irrigation of lumbar wound.Application of wound vac lumbar wound.On (b)(6) 2010: the patient underwent x-rays in ap and lateral views of the lumbar spine.The two views of the lumbar spine were obtained and showed the screws to be in appropriate position.The doctor did not see any lucency around the hardware.There were staples still in place on the ap view.There was bone formation present on the lateral view as well as on the ap view.There was bone present in the posterolateral gutters as well.On (b)(6) 2010: the patient underwent x-rays in ap and lateral views of the lumbar spine.The x-rays showed the screws to be in appropriate position.No signs of loosening.There was bone formation in the interbody space at l5-s1 and bone forming in the posterolateral gutters as well.On (b)(6) 2010: the patient underwent x-rays in ap and lateral views of the lumbar spine.Two views of the lumbar spine were reviewed and showed that the patient had a stable fixation of the implant.There appeared to be bone forming on the posterior lateral aspect of the gutters at l5-s1.There was also bone formation present between the interspace at l5-s1 as well.No lucency was seen around the screws.On (b)(6) 2010: the patient underwent x-rays in ap, lateral, flexion/extension views of the lumbar spine.Four views of the lumbar spine were reviewed and showed that the patient had stable fixation of his implants.The doctor did not observe any lucency around the screws nor any backing out of the screws.On (b)(6) 2010: the patient underwent a ct scan and mri of the lumbar spine.Impression: the review of the ct scan revealed grade 1 anterolisthesis of l5 on s1 following interbody fusion with pedicle screw placement.There was some early consolidation of posterolateral graft on the right side.No definitive interbody fusion was present beyond a small bony bridge of spur along the annular margin of the disk space just to the left of midline.Mri of lumbar spine with and without intravenous contrast was also reviewed and showed some foraminal stenosis present on the left side at the l5-s1 area.Impression: grade 1 anterolisthesis of l5 on s1 following previous posterior decompression and interbody fusion with pedicle screw placement.There was severe left and moderate right l5-s1 foraminal stenosis.On (b)(6) 2010: the patient presented with a left l5-s1 radiculopathy and pseudoarthrosis at l5-s1.Procedure: posterior spinal fusion l5-s1; posterior non-segmental instrumentation l5-s1; l5-s1 laminectomy with facetectomy l5-s1; reduction of the spondylolisthesis l5-s1 5.Use of local bone graft and posterolateral fusion mass ct scan was obtained that showed that the patient had formed bone within the canal in the lateral recess at l5-s1.The patient also did not have conclusive evidence of radiographic healing of his fusion mass.The surgeon performed an operative procedure involving three stages.Stage one consisted of an exploration of the fusion mass at l5-s1 with removal of the posterior non segmental instrumentation l5-s1.Stage two consisted of an anterior lumbar interbody fusion l5-s1, anterior lumbar discectomy with decompression l5-s1, and use of allograft x2.Stage three consisted of a posterior spinal fusion l5-si, posterior segmental non segmental instrumentation l5-s1.L5-s1 laminectomy and facetectomy l5-s1.Reduction of the spondylolisthesis l5-s1.Use of local bone graft and posterolateral fusion mass.There were no noted patient complications.Depuy expedium with 6.35mm rods were also used in the surgery.On (b)(6) 2010: the patient presented himself for follow-up for his posterior anterior posterior l5-si fusion, revision.Two views of the lumbar spine were reviewed and showed that the patient had a stable fixation of the implant from l5 to s 1.The bone graft appeared to be consolidating within the interbody space.Impression: status post a 540 lumbar fusion ls-si.On (b)(6) 2011: the patient presented himself for follow-up from l5-s1 repair of pseudoarthrosis.His leg pain was becoming less intermittent.His back pain was the best it has felt in a long time.Otherwise he is pretty pleased at this point in time.Two views of the lumbar spine were obtained and show the patient has stable fixation of the implants at l5-s1.There was consolidation of interbody grafts.On (b)(6) 2011: the patient underwent x-ray of lumbosacral spine.Impression: the patient has stable fixation of the implants from l5- s1 and complete union of the l5-s1 fusion.The doctor did not observe any lucency in the screws.On (b)(6) 2011: the patient underwent a ct scan of lumbar spine due to low back pain and left leg pain.Impression: 1.Intact disk space fusion at l5-s1.Moderate-to-severe lef1 foraminal stenosis at l5-s1 from an endplate osteophytic ridge.On (b)(6) 2012: the patient presented for follow-up with spinal cord stim and left leg pain.The location of pain was lower back and left flank.Symptoms were aggravated by bending, daily activities, sitting, standing and walking.The patient felt a pop in the back with immediate onset of lbp without radiation into lower extremity.The doctor suggested to continue with the scs therapy and started him with myofascial release pt and flexeril 10mg po bid on a scheduled basis with pt.On (b)(6) 2012: the patient underwent a trigger point injection under fluoroscopic guidance due to myofascial back pain with overlying spinal cord stimulating lead hardware.The patient tolerated the procedure well without any apparent complications.On (b)(6) 2012: the patient presented for follow-up with back pain radiating to left leg.The problem was worsening.The trigger point injection was not helpful.Continues with left paravertebral muscle pain extending into buttock.No new numbness, weakness or tingling.No bowel/bladder changes.On (b)(6) 2012: the patient presented for follow-up with back pain radiating to left leg.The problem was fluctuating and occurred persistently.Location of the pain was lower back and the pain has radiated to the left thigh.The patient had refractory lbp with lle radiating of pain and there was no improvement with injections.During the patient¿s previous visit the doctor had started on ms contin 15mg po bid.On (b)(6) 2012: the patient presented for follow-up with back pain radiating to left leg.During his previous visit the doctor had increased his ms contin dosing to 30mg po bid but couldn¿t notice any substantial improvement.On (b)(6) 2012: the patient presented for follow-up with back pain radiating to left leg.During his previous visit the doctor had rotated opioids to methadone 10mg po tid.On (b)(6) 2012: the patient presented for follow-up with back pain radiating to left leg.The doctor increased his methadone dosing to 10mg po tid.On (b)(6) 2013: the patient presented himself for follow-up with severe back pain radiating into left leg.The location of the pain was lower back.During the last visit the doctor had increased his methadone to 10mg pot id and notes that it has helped the patient.On (b)(6) 2013: the patient presented himself for follow-up with low back pain radiating into left leg.The patient continued on methadone 10mg po tid and also usage of tramadol 50mg 1-2 bid pm.The doctor had also added diclofenac but it did not alter his conditions.On (b)(6) 2013: the patient presented himself for follow-up with low back pain radiating to the left foot.The patient described the pain as an ache, shooting and stabbing.The symptoms aggravated y standing and walking.The symptoms were relieved by pain meds/drugs.On (b)(6) 2013: the patient underwent a ct lumbar without contrast due to low back pain radiating down the left leg.Impression: expected postoperative changes from posterior interbody fusion spanning l5-s1 with an intact posterior fusion construct and solid osseous fusion across the disc space 2.Osteophytic ridging extends into the left neural foramen at the l5-s1 level resulting in a moderate degree of left-sided neural foraminal stenosis 3.Mild disc and facet degenerative changes at l 4-5 and mild disc degenerative changes at l3-4 do not result in significant compromise of the lumbar spinal canal.There is mild bilateral neural foraminal stenosis at the l4-5 level.On (b)(6) 2013: the patient presented himself for follow-up with his failed back syndrome and severe back pain.The patient had been on methadone 20mg bid which was rotated to ms contin 30mg bid and he feels that his pain has been worse since then.
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(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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