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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
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| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Muscle Weakness (1967); Pain (1994); Tingling (2171); Stenosis (2263); Neck Pain (2433); Nerve Proximity Nos (Not Otherwise Specified) (2647)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a posterior-approach lumbar fusion at level l5-s1 using rhbmp-2/acs.The patient's post-operative period was marked by increasingly severe pain.Imaging studies ultimately showed that patient had developed uncontrolled bone growth and resulting nerve compression at the surgery site.Patient has bone overgrowth, nerve compression, chronic pain and radiculitis and is required to undergo revision surgery to attempt to remove the bone overgrowth.
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Manufacturer Narrative
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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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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2011 the patient underwent ct of head or brain w/o contrast.Impression: no acute intracranial hemorrhage seen.No acute infarct was present.Ventricular system appears normal.There may be some slight periventricular white matter hypointensities present also suggesting underlying chronic microvessel changes.There are also some atherosclerotic changes in the distal internal carotid arteries.On (b)(6) 2012 the patient was diagnosed for hypertension, cervical disc displacement, lumbar disc displacement.On (b)(6) 2012 the patient returns today for a follow-up and scheduled pump refill.She was complaining of pain across the lower back with radiation into the lower extremity.She has been experiencing excessive daytime somnolence.On (b)(6) 2013: mri of the lumbar spine: complex postoperative changes represent posterior interbody fusion l3-5 with pedicle screw and fusion rad device with accompanying laminectomies and placement of bone graft in the l4-5 disc space.Patient also appears to undergone fusion at l2 l3 without posterior hardware.Small bulgy towards the right at t12-l1 with right-sided facet arthropathy and very mild central stenosis.Asymmetric bulge towards the right at l1-2 and right-sided facet arthropathy which blunting of the right anterolateral recess and mild central stenosis.Bimodal bulge at l2-3 asymmetric towards the right with right-sided facet arthropathy and blunting of the right anterolateral recess and overall moderate central stenosis.Bulge touches the right l3 within the anterolateral recess.No definite disc herniation or central stenosis at l3-4 or l4-5 or l5-s1.Facet arthropathy at the l5-s1 level without nerve root compression.The patient underwent mri of cervical spine w/o contrast.Impression: again noted is postsurgical changes of cs/6 fusion and c3-cs laminectomy.Alignment is anatomic and vertebral body height is maintained.There are no acute findings; multilevel disc and facet degenerative changes as outlined above similar appearance to the prior mri performed (b)(6) 2010.There is multilevel wild cord flattening but no signal changes to suggest myelomalacia or edema.No area of high-grade canal stenosis but there is multilevel mild/moderate and severe neuroforaminal narrowing.On (b)(6) 2013 mri of the thoracic spine: multilevel is a moderate degenerative thoracic disease changes with mild degenerative thoracic spine scoliosis.No significant thoracic spinal canal stenosis or prominent thoracic disc herniation at any level.Normal appearance of the thoracic spinal cord.On (b)(6) 2013 the patient returns today for a follow-up and scheduled pump refill.Patient tolerated procedure well without any apparent complications.On (b)(6) 2013: the patient presented with complaints of lower back pain radiating across her lower lumbar spine in a belt-like fashion with pain in her right buttock as well as pain into the bilateral lower extremities most significantly into the anterior portions of her thighs bilaterally.She admits to some occasional numbness and tingling into the anterior thighs bilaterally.Assessment: cervical degenerative disc disease and spondylosis causing cervicalgia; thoracic spondylosis causing thoracic back pain; lumbar degenerative disc disease, spondylosis, and scoliosis impairing her ability to even stand upright, and she stands and sits leaning to the right side.She shows severe muscle atrophy of those muscles.She does have levoscoliosis noted, but if is only mild to moderate in nature.(b)(6) 2013 : patient was diagnosed with cervicalgia, lumbago, idiopathic scoliosis, abnormality of gait, muscle weakness.On (b)(6) 2013: the patient suffers from chronic lower back which radiates into both lower extremities in the l2, l3 and l4 distribution.She underwent back surgery.She has significant back pain component which is aggravated by sustained upright posture.On (b)(6) 2013: patient presented for follow-up.Patient presented with low back pain radiating into the bilateral anterior thighs as well as cervical neck pain and thoracic back pain.On (b)(6) 2013 the patient presented with the following pre-op diagnosis: failed back.Patient has had cervical and lumbar fusions with severe back and leg pain.The patient underwent: in-office spinal cord stimulator trial with boston scientific 16-lead infineon stimulator, intra-op fluoroscopy.Complications none.(b)(6) 2013 the patient returns today for a follow-up and scheduled pump refill.She was reporting chronic symptoms of pain across lower back.On (b)(6) 2013 the patient underwent x-ray of chest.Impression: somewhat limited chest but no obvious acute consolidation or vascular congestion.On (b)(6) 2013: patient presented with intractable back and leg pain.Patient underwent t9 and t8 laminectomy for spinal cord stimulator paddle placement, boston scientific, with placement of generator "posket".Patient underwent anterior posterior lumbar decompression fusion with decompressive laminectomy.On (b)(6) 2013 the patient presented for evaluation for postmenopausal atrophic vaginitis.The presenting complaint is vaginal irritation with no discharge.These have been present for the past 24 months.Associated symptoms include dyspareunia and vaginal dryness.Assessment: postmenopausal atrophic vaginitis.On (b)(6) 2013 the patient underwent l4, l5 and s1 lumbar decompression and fusion.Findings: poor bone quality.On (b)(6) 2013 the patient came for a follow-up.Assessment: the patient, who had a permanent spinal cord stimulator, placed in (b)(6) 2013, states that her pain has gradually returned.On (b)(6) 2013 patient returns today for a follow-up and scheduled pump refill.She is complaining of pain across the lower back in both lower extremities.Today, she has requested escalation of the intrathecal "dilaudid" therapy.Patient tolerated procedure well without any apparent complications.On (b)(6) 2013 ct l spine w/o contrast: chronic degenerative disease at l2-3 causing moderately severe canal and bilateral lateral recess stenosis.There appears to be anterlisthesis of l3 on l4 new from the prior study despite posterior fusion and lateral fusion.Multilevel degenerative disc disease which is moderately severe.Prior lateral fusion l2-3 and posterior fusion l4-s1.Prior bilateral laminectomies l3-4.Ct c spine w/o contrast: prior bony fusion c5-6.Prior bilateral laminectomy c4-c6.Advanced degenerative disc disease c4-5 and c6-7.Bilateral uncovertebral joint spurring causing foraminal stenosis at c4-5 which may impinge upon the exiting c5 nerve roots.Ct t spine w/o contrast (b)(6) 2013: multilevel mild degenerative disc disease with no acute findings.Neural stimulating device in place posteriorly at about t6-7.Small epidural catheter in the lower thoracic spine extending from below not completely seen in this film.No acute findings.On (b)(6) 2013 the patient was diagnosed for chronic lower back and bilateral lower extremity pain, bilateral lumbar radiculopathy.On (b)(6) 2013 the patient came for a follow-up for atrophic vaginitis.Assessment: postmenopausal atrophic vaginitis.On (b)(6) 2013 the patient was diagnosed for severe cervical and lumbar back and leg pain and thoracic and cervical neck pain.On (b)(6) 2013 the patient came for a follow-up due to a severe deformity of the spine with 45' hunched in forward flexion and positive sagittal imbalance; however, from the front, she had a significant coronal imbalance as well.She had failed injections, conservative care, medical management, therapy, and activity modification.The patient underwent ct of the lumbar spine.The ct shows that the screw is fragrantly loose with positive halo at l3 showing there is no fusion concerning whether there are vacuum phenomenon changes in the facets between l3 and l4.L4 and l5 have positive fusion.There was fusion with a lateral fusion at l2-3.She has a scoliosis between l3 and l4.The apex of her lordosis was also at l3-4, placing tremendous forces on this region.She also has vacuum changes at the ls-s1 facet complex, particularly on the right.On (b)(6) 2014: patient presented with follow up.Impression: progressive spinal deformity with kyphoscoliosis and intractable pain.Loose pedicle screw at l3.Presence of unilateral screw.On (b)(6) 2014 the patient presented with the following pre-op diagnosis: chronic cervicalgia and facet osteoarthropathy, cervical spondylosis.The patient underwent: fluoroscopically directed right cervical c2, c3, and c4 median branch nerve block.Complications none.On (b)(6) 2014 the patient underwent x-ray of chest.Impression: slightly increased pleural parenchymal markings at the left lung base are very similar to previous exam.On (b)(6) 2014 the patient underwent x-ray of chest 2 views.Impression: no acute cardiopulmonary disease.On (b)(6) 2014: patient underwent revision posterior approach lumbar spine, removal of the screws with finding of nonunion and l2 through s1 fusion and fixation.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that on (b)(6) 2002: the patient presented for consultation.The patient presented with preoperative diagnosis of small pneumothorax and hem othorax on left, left scapular fracture, left first and second rib fractures.On (b)(6) 2004: the patient underwent mri of the lumbar spine without contrast.Impression: no sonographic evidence of dvt within the bilateral lower extremities, bilateral peroneal veins not visualized.On (b)(6) 2004: the patient presented for office visit.On (b)(6) 2004: the patient underwent x-ray ap and lateral flexion extension lumbar spine.Impression: there is approximately 4mm of an terolisthesis at the same level on flexion x-rays.There is mild to moderate osteopenia.The patient presented with chief complaint of pain in ankles and numbness.On (b)(6) 2005: the patient presented for office visit.On (b)(6) 2005: the patient presented with chief complaint of mental disorder.On (b)(6) 2005: the patient underwent mri lumbar spine without contrast.Impression: severe osteoarthritic and degenerative disc changes at multiple level most prominent at l4-5 with 2 to 3mm of anterolisthesis and disc uncovering with a diffuse bulge with moderate canal stenosis and some lateral recess narrowing, there is mild canal stenosis noted at l3-4 with some minimal narrowing of the thecal sac at l2-3, at l2-3 there is a left far lateral protrusion with associated annular tear, l5-s1 demonstrates a focal central prostrusion with associated annular tear.On (b)(6) 2005: the patient underwent bone densitometry examination.On (b)(6) 2005: the patient underwent x-ray ap and lateral flexion extension lumbar spine.Impression: there is grade 1 listhesis at l4-5 with movement from 4 to 7mm on dynamic testing.This is unchanged from previous x-ray.Incidental note of mild vascular calcification of the aorta is made.There is adequate lumbar lordosis.The patient presented for office visit.On (b)(6) 2005: the patient presented with chief complaint of lumbar stenosis.On (b)(6) 2005: the patient presented with chief complain of leg pain and difficulty in walking and standing and underwent mri.Ros revealed: musculoskeletal: joint pain, neurological: headache, dizziness, psych: depression, anxious (b)(6) 2005: the patient underwent dopp- venous lower bilateral examination.On (b)(6) 2005: the patient presented for office visit with chief complain of flu.On (b)(6) 2005: the patient underwent physical examination.The patient underwent x-ray ap and lateral lumbar spine.Impression: the patient is status l3 through l5 fusion with internal fixation and l4-5 interbody cage placement with an l4 gill laminectomy.The transverse process fusion is visible in the transverse process region bilaterally at l3 through l5.Incidental note of calcific vascular disease is made.On (b)(6) 2005: the patient underwent ap and lateral flexion-extension lumbar spine x-rays.Impression: the patient is status post an l3 through l5 fusion with internal fixation and l4-5 interbody cage placement there are pedicle screws at l3, l4 and 5 on the left side and l4 and 5 on the right side.Bony material is seen within the interbody cages but the fusion in this region is not complete.The patient presented with chief complaint of lbp better by 50-60%.On (b)(6) 2006: the patient presented for office visit with complaint of buttock pain and muscle weakness.The patient underwent ap and lateral lumbar spine x-ray.Impression: the patient is status post an l3 through l5 fusion with internal fixation with interbody cage placement at l4-5.There are screws on the left side at l3 through l5 and on the right side at l4 and l5.Bone is seen in the transverse process region at l4-5 on the right side, but is not seen at l3-4 on the right side or l3-4 on the left side.There is a smaller amount of bone on the left side at l4-5 in comparison to the right side.Adequate bone density is seen within the interbody cage atl4-5 on the lateral x-rays.There are no lucencies around any of the screws atl3,l4, or l5.Findings are compatible with a completed fusion atl4-5.Follow up x-rays to evaluate the fusion status atl3-4 would be beneficial at that level in the future.Incidental note is made of calcific vascular disease and loss of disk height atti2-ll,ll-l2, and to a lesser extent at l2-3.On (b)(6) 2010: the patient underwent mri of lumbar spine.Impression: re-demonstration of postoperative appearance of the lower lumbar spine, unchanged from prior examination; re-demonstration of diffuse disc buldge spanning t11-t12 through l3-l4; re-demonstration of focal high grade spinal stenosis across the l2-l3 disc interspace where there is a fixed retrolisthesis.The patient underwent mri c-spine without contrast.Impression: no acute cervical injury identified, c5-c6 vertebral body fusion, unclear if this is iatrogenic or congenital, apparent laminectomy from c4 through c6.On (b)(6) 2010: the patient presented for office visit for evaluation of chronic lower back pain.On (b)(6) 2010: the patient discharged with diagnosis of severe degenerative lumbar spine disease.On (b)(6) 2010: the patient underwent lumbar spine ap and lateral 2 views.Impression: the patient is status post recent fusion with vertebral body screws at l2-l3 and old fusion at l3-l4 and l4-l5 with pedicle screws.The hardware is stable as compared with intraoperative examination and there is satisfactory alignment of the vertebrae.On (b)(6) 2010: the patient presented for office visit.On (b)(6) 2010: the patient came for an office visit for a post operative appointment from a left l2/3 xlif, l2/3 internal fixation that was performed on (b)(6) 2010.On (b)(6) 2010: the patient underwent lumbar spine 2 views: impression: new postop change at l2-3 scoliosis degenerative changes similar to previous.On (b)(6) 2010: the patient presented for office visit for a post operative appointment for a left l2/3 xlif, l2/3 internal fixation.On (b)(6) 2010: the patient presented for office visit.For discussion mid back pain and right knee pain.On (b)(6) 2011 the patient presented for a reevaluation od a leftl2/3 xlif (with interbody cage and interbody fusion); l2/3 internal fixation (rh-bmp2/acs' formagraft fusion) that was performed on (b)(6) 2010.The patient underwent lumbar spine complete.Impression: unchanged from prior exam.On (b)(6) 2011: the patient presented for office visit to follow up with new mri cervical and lumbar.Review of mri performed revealed: impression: patient has failed back syndrome, and piriformis muscle syndrome as well.I do not think further surgery will help.I do not see any evidence that her residual foraminal stenosis at l2-3 is symptomatic.My recommendations for her are as follows: patient needs to be referred to a rheumatologist for her polyarthritis; patient claims that she has been taken off numerous medications due to liver and kidney problems.I am not sure of the extent of this and will defer to dr regarding medical management of her pain gabapentin or lyrica for her leg pain.She also is on effexor for depression and cymbalta may be a reasonable alternative given its effect on pain, but i will refer it to on this.She may benefit from trigger point injections in the muscle given that her piriformis muscle stretch are abnormal bilaterally, and she has piriformis muscle pain bilaterally, as well as bilateral leg pain involving the anterior thigh lesion, as well as the entire leg.I would refer to dr.Additionally, muscle relaxants help further suggesting that the piriformis may cause some of her radicular symptoms in the legs, when there is piriformis muscle spasm.She should also continue piriformis muscle exercises, which i have given her; patient should continue with her syncope workup under the direction of dr, for patient should continue keeping her blood pressure under'control and this is being stabilized under the care of dr.; patient has a morphine pump, which does help her, however, patient is having breakthrough pain and lancinating groin pain.This may be due to failed back syndrome.I will refer to dr regarding whether a trial of a spinal cord stimulator in this setting may be worthwhile, although admittedly this is a very complex problem given that the morphine pump is quite helpful for the patient.I personally have no opinion either way as to the best way to manage this complex set of problems from a pain management perspective and we will refer to dr opinion; i will see her back in 2years.She does have some foraminal stenosis atl2-3 that is residual, but i do not think this is particularly symptomatic; of note, i did not detect any myelopathy and i do not think that her cervical spondylosis is symptomatic.,.
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