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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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| Catalog Number 7510800 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ossification (1428); Chest Pain (1776); Dyspnea (1816); Edema (1820); Fatigue (1849); Headache (1880); Hepatitis (1897); Nerve Damage (1979); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Weakness (2145); Tingling (2171); Chronic Obstructive Pulmonary Disease (COPD) (2237); Stenosis (2263); Numbness (2415); Sleep Dysfunction (2517); Ambulation Difficulties (2544); No Code Available (3191)
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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 transforaminal lumbar interbody fusion and a posterolateral fusion at l4-5 where rhbmp-2/acs was placed in the disc space and lateral gutters.The patient's post-operative period was followed by a temporary period of relief from pain and has subsequently been marked by pain and weakness in his legs.The patient continues to experience pain that radiates into his lower extremities.
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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) 2013: patient presented for follow up and rated his pain as 8 on scale of 10 with 10 having worst pain possible and 0 having no pain at all.Musculoskeletal review revealed mild tenderness of the bilateral facet joints and bilateral paraspinal tenderness present.Diagnoses: lumbosacral spondylosis without myelopathy; other back symptoms; lumbar or lumbosacral disc degeneration; post laminectomy syndrome of lumbar region.(b)(6) 2013: patient presented for follow up.Diagnoses: lumbosacral spondylosis without myelopathy; other back symptoms; lumbar or lumbosacral disc degeneration; post laminectomy syndrome of lumbar region.(b)(6) 2013: patient underwent bi lateral lumbar facet joint/medial branch block injection.Patient tolerated procedure well.Musculoskeletal review revealed mild tenderness of the bilateral facet joints and bilateral paraspinal tenderness present.Diagnoses: lumbosacral spondylosis without myelopathy; other back symptoms; lumbar or lumbosacral disc degeneration; post laminectomy syndrome of lumbar region.(b)(6) 2013: patient underwent bi lateral lumbar facet joint/medial branch block injection.Patient tolerated procedure well.Diagnoses: lumbosacral spondylosis without myelopathy; other back symptoms; lumbar or lumbosacral disc degeneration; post laminectomy syndrome of lumbar region.(b)(6) 2013: patient underwent x-ray of lumbar spine which demonstrated degenerative dextroconvex scoliosis with a rotatory component.It is worse from l3 down to the sacrum, and straightens up by about l2.He has had a previous fusion, instrumented at l4-5.The hardware appears to be intact, and there is no sign of hardware failure or pull out of the screws.(b)(6) 2015: patient underwent x-ray of lumbar spine which demonstrated good positioning of the hardware from l3 to the sacrum.The anterior lumbar interbody fusion and interbody cages are in good position and there appears to be solid bone graft out laterally.There is no sign of haloing.(b)(6) 2015: patient presented with low back pain.(b)(6) 2013: patient underwent x-ray of lumbar spine which demonstrated degenerative dextroconvex scoliosis with a rotatory component.Conclusion: no evidence of fracture.Intact l4-5 fusion.(b)(6) 2013: patient underwent chest x-ray for preoperative evaluation.Conclusion: normal examination.(b)(6) 2013: intraoperatively, patient underwent lumbar spine x-ray.Conclusion: no evidence of retained surgical instrument.(b)(6) 2011 the patient was admitted to er with the complaints of weakness, paresthesia, fatigue, headache, intermittent chest pain.He has had weakness and tingling.The patient also has had difficulty breathing, numbness, (from the waist up bilaterally).Ekg showed normal sinus rhythm.Ct of the head showed no acute findings.X-rays of the chest showed no acute disease.(b)(6) 2011 the patient underwent complete two-dimensional transthoracic echocardiogram due to paresthesia.On (b)(6) 2011, patient underwent for mri lumbar spine without contrast for back pain with radiculopathy.(b)(6) 2012 the patient presented for physical therapy.Last night, he felt/heard a loud pop in his upper back and got excruciating, shooting pain in his back.01/24/2012 the patient presented for physical therapy.He still presented with lumbar extension deficits.(b)(6) 2012 the patient presented for physical therapy and reported that the pain is overall much better.However the pain still tends to throb in the lower left portion of his back.(b)(6) 2012 the patient was admitted to er due to back injury and pain.The pain was described as being mild and in the area of the lower lumbar spine.(b)(6) 2012 the patient presented with constant lbp and radiating pain in his low and mid back.The pain was described as constant throbbing in mid and low back.(b)(6) 2012 the patient presented for physical therapy and reported increased pain.(b)(6) 2012 the patient presented for physical therapy and reported that back is getting worse.He stated that he has numbness throughout his toes on his left foot.(b)(6) 2012 patient reported no change with therapy.He has increased pain in the low back, trouble sleeping, and trouble getting out of bed, unable to push up with left le to ascend a step without the leg buckling.Assessment: patient demonstrated poor movement mechanics, unable to progress with exercises secondary to pain.(b)(6) 2012 the patient presented for physical therapy.The patient went for a long drive and had 4/10 dull ache in the low back.Left leg continued to be weak.Trouble sleeping since he went for ride.(b)(6) 2012 the patient presented for physical therapy.Patient states he experiences more pain at night and first thing in the morning, and also after he has been sitting or lying down for a while.Patient stated that he can only tolerate walking one block before his back starts to bother him.Patient also stated that going up steps is still difficult and that is (l) le is weaker but he is trying to use his (l) le more but it causes pain in his low back.(b)(6) 2012 the patient presented with the pre op diagnosis of screening.The patient underwent colonoscopy.The post op diagnoses were: internal hemorrhoids; normal colon and rectum; no polyps.No patient complications were noted.(b)(6) 2013 the patient underwent stress/rest myocardial perfusion imaging with quantitative gated spectral analysis due to chest pain.(b)(6) 2013 the patient presented with the chief complaint of chronic back pain.The pain is described as being severe and in the area of lumbar and sacrum.The quality is noted to be aching and similar to prior episodes.(b)(6)2015 the patient presented with the history of lesions on legs present for months, increasing in size, inflamed seborrheic keratosis, and rule out basal cell carcinoma.The dermatopathology report showed epidermal acanthosis and papillomatosis with overlying hyperkeratosis.No significant squamous atypia is appreciated.The lesion is associated with a superficial lymphohistiocytic infiltrate.Overall, these findings are most consistent with an inflamed seborrheic keratosis.There is no evidence of malignancy.(b)(6) 2012: patient underwent x-ray of lumbar spine seven views including lateral views in neutral, flexion and extension and is co mpared to (b)(6) 2011 and to the mri of lumbar spine done (b)(6) 2011.(b)(6) 2013: the patient admitted to the hospital with a history of disability, lumbar stenosis, osteoporosis and spondylolisthesis.Patient presented with pre-op diagnosis of dyspnea on exertion and abnormal stress test.Patient underwent selective bilateral coronary angiography; left heart catheterization; left ventriculogram.Post-operative diagnosis of angiographically normal coronary arteries.(b)(6) 2013: patient presented with history of low back pain and falls on knee, slip.(b)(6) 2013: the patient presented with low back pain.Patient underwent lumbar myelogram with post ct (b)(6) 2013: the patient resented for follow-up.Patient was still experiencing axial back pain.Patient was sent to pain clinic.(b)(6) 2013: patient underwent ct of lumbar fusion due to low back pain, prior fusion.Conclusion: status post l4-l5 fusion.Solid osseous fusion across the disc space and posterior elements.No abnormal lucency adjacent to the surgical hardware.The thecal sac is well decompressed; mild to moderate spinal canal stenosis at l3-l4, mild l2-l3.No nerve root compression; mild chronic l1 and l2 compression features.Patient underwent lumbosacral myelography due to back pain.Conclusion: there are post-operative changes of prior posterior and interbody fusion as well as laminectomies.There were mild ventral impressions on the intrathecal contrast column above the level of fusion.(b)(6) 2009: the patient presented to discuss er results, chest x-rays.Patient stated he had (b)(6), arm numbness and chest pain.Assessment: nocturnal cough/ dyspnea.(b)(6) 2011: the patient presented with ears plugged.Patient was having trouble in hearing.(b)(6) 2011: the patient presented with left lower back pain, numbness and tingling down his left leg.(b)(6) 2011: the patient presented with lower back pain.Patient had been wearing belt but it did not bother him.(b)(6) 2012: the patient presented for follow-up on spinal stenosis- back pain.Assessment: spinal stenosis, chronic back pain.(b)(6) 2012: the patient presented with complaint of anxiety.Assessment: depressive disorder nec, chronic (b)(6) w/o hepatic coma, lumbosacral spondylosis.(b)(6) 2012: the patient presented for follow-up and was having trouble in sleeping.Assessment: depressive disorder nec, lumbosacral disc degeneration.(b)(6) 2012: the patient presents with complaints of ear plugged, wurstions about (b)(6) shots, wanted tdpa shot and colonoscopy.Assessment: impacted cerumen, chronic (b)(6) w/o hepatic coma, lumbosacral disc degeneration, tobacco use disorder, screen mal neop-colon.(b)(6) 2013: the patient was presented with blisters in mouth and on tops of b feet, l foot toenail fell off.(b)(6) 2013: the patient was diagnosed with chest pain.(b)(6) 2013: the patient presented for pain management for back pain and wanted new back brace and lidoderm patch instead of cream.Assessment; lumbosacral spondylosis; lumbosacral disc degeration.(b)(6) 2013: the patient presented for follow-up on back pain, blisters on feet and going up ankles, blisters in mouth.The patient was assessed with depressive disorder nec and lumbosacral disc degeneration.(b)(6) 2013: the patient presented for follow-up of back pain and needed rx for walker.On (b)(6) 2013, patient presented for an ambulatory assessment for pre surgical clearance.Assessment; lumbosacral spondylosis; lumbosacral disc degeration.(b)(6) 2014: the patient was assessed with depressive disorder nec, lumbosacral spondylosis, lumbosacral disc degeneration.(b)(6) 2014: the patient was assessed with lumbosacral spondylosis, vitamin d deficiency.(b)(6) 2015: the patient presented with scaly sessions to legs for months getting larger.Assessments: (b)(6), lumbosacral spondylosis, neoplasm of skin.
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Manufacturer Narrative
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(b)(4).
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Event Description
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Patient reported l4-l5 stenosis; l4-l5 spondylolisthesis, causing back pain and numbness in left leg and toes led to his first rh-bmp2 treatment and post-op, lumbar degenerative scoliosis; lumbar spndylosis; lumbar foraminal stenosis, causing back pain and numbness in left leg and toes led the patient to have another rh-bmp2 treatment.On 2012, patient presented with diagnosis of back pain; numbness down left leg and toes and underwent physical therapy.Post-op infuse treatment, patient alleged injuries including, but are not limited to bone overgrowth; revision surgery; numbness in back, legs, and toes; severe and constant back pain; radiating pain to legs; difficulty breathing; localized edema; nerve injury; mental anguish; depression; and erectile dysfunction.Patient currently use a walker to get around due to pain and numbness and also using an empi tens unit for pain.Patient reported that approximately 5 months prior to patient's first infuse surgery, he injured his back and was no longer able to do the physical activities.
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Manufacturer Narrative
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Image review: (b)(6) 2012 intraop x ray.Localizing instrument at l4-5 (b)(6) 2012 intraop flouro interbody graft present, unilateral l4-5 pedicle screws present, hardware placement appears appropriate (b)(6) 2012 chest x ray no comment (b)(6) 2013 nm bone spectroscopy no comment, report not available.On (b)(6) 2013 l spine x ray l4-5 interbody spacer and bilateral pedicle screws are present.Hardware intact.Degenerative scoliosis present above construct (b)(6) 2013 standing scoliosis ap/lateral xrays, curvature denoted on films, saggital balance ok, construct hardware is intact.On (b)(6) 2013 flex ex l spine x rays minimal movement above or below l4-5 is seen (b)(6) 2013 ct myelography l4-5 solid bony fusion is present in the facets and interbody space.Some bone formation is present posterior to the l4-5 graft on the left which may narrow the foramen on this side as well.Overall central canal diameter is preserved.On (b)(6) 2013 intraop fluouro l5 ¿s1 anterior interbody cage now present (b)(6) 2013 intraop fluouro sows revision to l3-s1 construct with l5-s1 anterior graft and l3-s1 pedicle screws.Hardware placement appears appropriate narrative impression: initial treatment was performed at l4-5 with a standard transforaminal lumbar interbody fusion.Bmp was used both in the interbody cage and lateral gutters by report.Post operative course complicated by second surgery for deformity including extension of fusion to l3 and s1 with both an anterior and posterior approach.Laterality of symptoms is not provided, but bony overgrowth seen on post op ct myelogram appears to affect the l lateral recess and l4-5 foramen more so than the right.Root cause: surgical technique.
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Manufacturer Narrative
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Concomitant products: cage, rods, screws, set screws (implant (b)(6) 2012, explant (b)(6) 2013).
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Event Description
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It was reported that the patient presented with preoperative diagnoses of l4-l5 stenosis, l4-l5 spondylolisthesis.The patient underwent the following procedures: l4-l5 laminectomy with bilateral l4 and l5 foraminotomies.Left-sided l4-l5 transforaminal lumbar interbody fusion with application of interbody cage.L4-l5 posterolateral fusion with implantable spinal instrumentation.The disc space of l4-l5 was exposed and entered.A discectomy at l4-l5 was performed using rongeurs.The endplates were prepared using curettes.A cage was seized to the disc space after endplate preparation.The bone that had been collected throughout the procedure from the patient was stuffed into the disc space along with some bone morphogenic protein.The cage was packed with bone morphogenic protein in the patient's own bone was then tapped into the disc space under lateral fluoroscopy.At this point, a morphogenic protein surrounding the patient's own autograft bone was laid out over the transverse processes that had been decorticated on the right side.At this point, pre-bent rods were sized and put into place.They were tightened down on to the screws with set screws.On (b)(6) 2012 the patient underwent x-rays of lumbar spine due to back pain, which demonstrated interval lumbar fusion l4-5, no acute findings, mild scoliosis and degenerative changes.On (b)(6) 2012, patient presented for a postoperative visit.Diagnosis: postoperative surgical exam, spondylolisthesis, lumbar stenosis.Impressions: patient was doing well in recovery from his surgery.On (b)(6) 2012, patient underwent examination of lumbar spine postop 4 months due to significant pain.Impression: relatively stable appearance of the lumbar spine without acute changes.Patient also underwent postoperative check with x-rays of his lumbar spine performed in same day.Radiology results: x-ray demonstrated degenerative lumbar scoliosis.Patient had hardware in place at l4-5.The spondylolisthesis appeared to be corrected.Interbody spacer was in place and appeared to be in good position.There was no sign of hardware failure, or any problems in that regard.On (b)(6) 2012, patient underwent for ct of lumbar spine without contrast for low back pain and post fusion status.Impression: status post lumbar fusion and laminectomy at l4-5 without identifiable complications.Pars interarticularis fracture on the left at l4 of indeterminate age.On (b)(6) 2012, patient presented for scheduled follow-up after having a ct.Radiology results: patient had degenerative scoliosis which curves a little bit above the level of l4-5 fusion.The spondylolisthesis at l4-5 is completely gone and reduced following the fusion.There was no sign of haloing.On (b)(6) 2012, patient presented for bone densitometry test due to disc degeneration.Impression: bone mineral density consistent with osteopenia/near borderline osteoporosis.On (b)(6) 2013, patient presented for an ambulatory assessment with back pain.Assessment: lumb/lumbosac disc design, lumbosacral spondylosis, depressive disorder nec.Following medication was discontinued: morphine sulfate 30 mg tab was discontinued.On (b)(6) 2013, patient presented with experience of axial back pain.On (b)(6) 2013, patient underwent for x-ray of lumbar spine flexion/extension.Conclusion: patient status post posterior rod and screw fixation at l4-l5, without significant change from prior examination.Patient also underwent for standing scoliosis study.Conclusion: dextroconvex scoliosis of 10.1 between t4 and t7.Dextroconvex scoliosis of 10.7 between l2 and l5.Satisfactory post operative appearance after anterior and posterior spinal fusion at l4-5.No visible acute fracture.Patient also underwent for nuclear medicine bone spect.Conclusion: focal radiotracer uptake in the right l4-l5 facet left l3-l4 and l4-l5 facets.Focal radiotracker uptake within the l4-l5 bone graft.On (b)(6) 2013, patient underwent for lumbosacral myelography with indication of back pain post fusion status.There were postoperative changes of prior l4-l5 posterior and interbody fusion as well as laminectomies.There were mild ventral impressions on the intrathecal contrast columns above the level of fusion.No myelographic block.Chronic compression fractures were noted.Patient also underwent for ct of the lumbar spine, post myelogram.Conclusion: status post l4-l5 fusion.Solid osseous fusion across the disc space and posterior elements.No abnormal lucency adjacent to the surgical hardware.The lethal sac was well decompressed.Mild to moderate spinal canal stenosis at l3-l4, mild l2-l3.No nerve root compression.Mild chronic l1 and l2 compression fractures.On (b)(6) 2013, (b)(6) 2013 patient presented with back pain.On (b)(6) 2013, patient presented for an ambulatory assessment for pre surgical clearance.On (b)(6) 2013, the patient underwent surgery from l4 and s1 (adjacent level and respective level).
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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) 2015 the patient was presented for office visit.Diagnosis: lumbosacral spondylosis and chronic insomnia.(b)(6) 2015, (b)(6) 2016 the patient was presented for office visit.Diagnosis: lumbosacral spondylosis and copd (chronic obstructive pulmonary disease).
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Event Description
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It was reported that on on (b)(6) 2012, patient presented for evaluation of low back pain.Assessments: the patient had grade 1 spondylolisthesis at l4-5, which caused moderate central canal stenosis and lateral recess stenosis, worse on the left side.He also had mild degenerative, dextroconvex scoliosis.
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Manufacturer Narrative
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Additional information: other relevant history.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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