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On (b)(6) 2007 the patient presented with pain and the preoperative diagnosis of lumbar disc disease, spinal stenosis, spondylolisthesis, and spinal instability.The patient underwent surgery which consisted of a lumbar decompression l4-l5-s1 with bilateral foraminotomies; l5-s1 posterior interbody fusion with application of bone dowels; l5-s1 posterolateral arthrodesis with posterior non-segmental and spinal instrumentation and morcellized local autograft bone supplemented with cancellous morcellized allograft bone.Bone obtained from the laminectomy and facetectomy was morcellized and placed in the lateral gutters at l5-51 and supplemented with cancellous morcellized allograft bone and bmp.On (b)(6) 2007, approx.10 days post op, the patient presented with back pain and mild erythema around the incision site.On (b)(6) 2007 the patient presented with some residual back and leg pain.X-rays showed bone dowels and instrumentation in good position.Fusion was uniting.On (b)(6) 2007 the patient presented with numbness and tingling in hands and neck pain and stiffness.An x-ray of the cervical spine showed disc degeneration at several levels.The most severe was at c3-4 and c5-6 where complete loss was noted at those spaces.On (b)(6) 2007 the patient presented with back and leg pain.Diagnosis: spinal stenosis, lumbar disc disease, spondylolisthesis, and sciatica.Medications: vicodin.On (b)(6) 2007 the patient presented with low back pain with left lower extremity radiculopathy.A mri of the lumbar spine demonstrated post-operative changes at l4-5 and l5-s1 without central canal stenosis; grade 1 anterolisthesis of l5-s1 with moderate left and mild to moderate right foraminal stenosis; moderate to severe bilateral foraminal stenosis at l4-5; moderate bilateral foraminal stenosis at l3-4; mild to moderate bilateral foraminal stenosis at l2-3; and postoperative changes with improvement in bilateral foraminal stenosis l5-s1 and l4-5.On (b)(6) 2007 the patient presented with back pain radiating into the thigh and groin areas.Diagnosis: of lumbar disc disease lumbar radiculitis and epidural fibrosis.Per the encounter notes the patient had undergone a lumbar spine mri scan which showed interval surgery at the l4-5 and l5-s1 levels with some remaining foraminal stenosis but well preserved central canal.There was some foraminal stenosis at the l3-4 level and l2-3 level without interval changes.On (b)(6) 2007 the patient presented with the diagnosis of lumbar disc displacement and neuritis and radiculitis.The patient underwent a bilateral l3 epidural injection.On (b)(6) 2007 the patient presented with back and leg pain.Per the encounter notes the patient had not received a substantial relief from the last epidural injection.On (b)(6) 2007 the patient presented with back and leg pain.Per the encounter notes, x-rays of the lumbar spine showed no signs of infection, fusion was uniting, the spine was in good alignment, and degenerative changes were noted above the fusion.On (b)(6) 2008 the patient underwent a lumbar spine x-ray which showed anterolisthesis of l5 on s1.There had been disc replacement of l5-s1.The degree of subluxation did not change with flexion or extension.On (b)(6) 2008 the patient presented with pain and underwent a whole body nm bone scan and spect which showed increased activity along the lateral bony fusion in the lower lumbar/lumbosacral spine; ventral osteophytes in the lower thoracic spine; increased activity in the mid left cervical spine attributed to facet degenerative change; degenerative change in the left shoulder, and medial weight bearing compartments of both knees and mid tarsal regions.On(b)(6) 2008 the patient presented with neck pain and bilateral hand numbness, right > left.The patient underwent a cervical spine mri which showed moderate to severe spinal canal stenosis at c3-4 level due to degenerative disc disease, diffuse disc bulge, and minimal retrolisthesis.There was mild dilatation of the central canal above this level, indicating mild syrinx due to cord compression.There was mild degenerative disc disease of c4-5 with a small central disc protrusion.There was no evidence of spinal canal stenosis.The neural foramina were mildly to moderately narrowed bilaterally; and degenerative disc disease of c5-6 with a broad-based disc protrusion.The bilateral neural foramina were moderately narrowed, greater on the left.The patient also presented with bilateral buttock pain and underwent a mri which showed status post bilateral laminectomy of l5-s1 with pedicle screws in adequate location.Enhancing scars were noted in the epidural space with encasement of existing nerve roots.The right neural foramen was moderately narrowed and the left neural foramen was severely narrowed.There was posterior fusion of l5-s1 with enhancing scars around the thecal sac.There was markedly narrowed bilateral neural foramina.Mild degenerative disc disease of l1-2, l2-3, and l3-4 with disc material desiccation and mild disc bulge were also seen.There was no evidence of spinal canal stenosis or significant narrowing of neural foramina.High signal intensities in the anterior aspect of the disc space of l1-2 with enhancement was suspicious for mild discitis.On (b)(6) 2008 the patient presented with bilateral hand numbness and low back pain.There was more numbness than pain suggesting a peripheral nerve issue.The patient also reported low back pain radiating into the leg.On (b)(6) 2008 the patient presented with lower back pain secondary to l5 pedicle screws impacting into l4-5 facet joint.Assessment: lumbar spondylosis, lumbar post laminectomy syndrome, cervicalgia, cervical spondylosis with myelopathy.A lumbar mri was reviewed which showed l5 adjacent to the l4-5 facet.A cervical mri was reviewed which showed c3/4 herniation with cord edema.On (b)(6) 2008 the patient presented with worsening axial pain.The remainder of the symptoms radiated into the groin area and posterior aspect of the thigh.The patient also reported stiffness and aching in both knees.Diagnosis: sciatica, lower back pain, and neuritis /radiculitis.On (b)(6) 2008 the patient presented with lumbago and received facet joint injections bilaterally l3- l4, l4-l5 <(>&<)> l5-s1.No patient complications were reported.On (b)(6) 2008 the patient presented with low back pain and hand numbness.The hand numbness was reported secondary to a c3-4 disk herniation and cord edema.The patient¿s low back pain was reported as secondary to screws impacting into the l4-5 facet joint.It was reported that the patient ¿had done nicely¿ after receiving a facet block.On (b)(6) 2008 the patient reported their back pain was worse after the surgery.Per the encounter notes the patient had had a good response to the facet block.It was noted that the patient was going to undergo a rhizotomy and if that ¿did not work¿ they would schedule a revision surgery to remove the screw hardware.On (b)(6) 2008 the patient presented axial back pain.The patient reported that they had received 50% improvement from their last lumbar facet joint injections ((b)(6) 2008) however the pain had worsened in the last two weeks.On 27 may 2008 the patient presented with the diagnosis lumbar strain/sprain and lumbar spondylosis and underwent intra-articular lumbar facet injections at l3-4 and l4-5 bilateral.No patient complications were noted.On (b)(6) 2008 the patient presented with continuing back pain.It was reported that the patient had failed to improve after a facet block and actually felt worse after the block.On (b)(6) 2008 the patient presented with continuing back pain.Assessment: post lumbar laminectomy syndrome.Other active problems listed: cervicalgia, cervical spondylosis with myelopathy, hypoesthesia/numbness in hands.
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(b)(6).(b)(4).Neither device nor applicable imaging studies were returned to the manufacturer for evaluation.Medical assessment: it is described that a patient began to have facet related pain at the l4/5 level after placement of an l5 to s1 pedicle screw construct.It is very possible that medial placement of a pedicle screw could cause facet impingement adequate to induce degeneration and/or pain.This is not directly a malfunction of the screw but rather a technique error placing the screw too close to the facet joint.The facet joint could also have easily been traumatized at the time of the surgery adequate to induce facetogenic pain.The source of this patient's back pain (coming from the l4/5 facet) can only be theorized and should not be taken as fact, however, the resolution of pain after facet block lends support to this theory being correct.Facet rhizotomy followed if unsuccessful by screw removal is a reasonable course, although removal of the screw at this point might very well not solve the problem as the damage has already been done.
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