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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
Fatigue (1849); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Stenosis (2263); Malaise (2359); Osteolysis (2377); Numbness (2415); Respiratory Tract Infection (2420); Sleep Dysfunction (2517); 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 on "(b)(6), 2012, the patient underwent a posterior lumbar interbody fusion (plif) at l3-4 and l4-l5 using a fusion cage made of peek.The peek cage was placed into the disc space along with rhbmp-2/acs.The bmp2 was also placed in the posterolateral aspects of the spine, bilaterally.Following surgery, the patient followed up with his physician.The patient began to develop radiating pain and stiffness in the back and legs.The patient has never recovered from surgery, and continues to experience daily, disabling pain that prevents him from performing many basic activities of daily living.".
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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.
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Event Description
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It was reported that on: (b)(6) 2004; (b)(6) 2005, the patient underwent laboratory examinations.(b)(6) 2005, patient presented with multiple medical problems.He was recommended for cbc, cmp, ha1c, and chest x-ray (b)(6) 2005, the patient presented with joint problem.He underwent ra factor evaluation.(b)(6) 2006, the patient presented for x-ray evaluation for lumbar spine.He complaint of back pain.(b)(6) 2006, the patient underwent mri lumbar spine after complaint of lower back pain.(b)(6) 2006, the patient presented with back pain, deep palpation and numbness.(b)(6) 2006; the patient presented for evaluation of his back pain, eye itching.(b)(6) 2006, the patient presented with ¿burt¿ right hip and experiencing difficulty.(b)(6) 2013, (b)(6) 2014: the patient presented for a follow up with complaints of low back pain which radiates to the bilateral lower extremities and is stopping at his feet.Impression: post-laminectomy pain syndrome; lumbar radiculitis; lumbar degenerative disc disease, lumbar spondylosis.(b)(6) 2014: patient presented with low back pain and bilateral lower extremity pain.Assessment: lumbar degenerative disc disease; lumbar radiculitis; lumbar spondylosis.(b)(6) 2014, (b)(6) 2015: the patient presented for a follow up.Impression: post-laminectomy pain syndrome; lumbar radiculitis; lumbar degenerative disc disease, lumbar spondylosis, lumbar facet arthropathy.(b)(6) 2015: the patient presented for a follow up today with complaints of low back pain with bilateral hip and leg pain radiating into his feet.Assessment: post-laminectomy pain syndrome; lumbar radiculitis; lumbar degenerative disc disease, lumbar spondylosis, lumbar facet arthropathy.(b)(6) 2015 the patient presented today for follow-up complaining mainly of low back pain.Impression: 1.Post laminectomy pain syndrome of the lumbar spine.2.Lumbar spondylosis.3.Lumbar disc disease.4.Lumbar facet arthritis.(b)(6) 2012: patient presented for an office visit with degenerative disc disease.(b)(6) 2012: patient presented for a visit with back and bilateral leg pain.Patient underwent: 1.Fluoroscopic-guided l4/l5 disc injection and discography.2.Fluoroscopic-guided l5/s1 disc injection and discography.No complications were reported.Patient underwent ct of the lumbar spine without contrast.Impression: discogram demonstrating moderate degenerative disc disease at l3-l4 classified as modified dallas score 4.There was moderate to severe degenerative disc disease at l4-l5 with extravasation of discogram contrast into the lateral foramina on the right and left consistent with high-grade annular tear.31 aug 2015: the patient presented for follow up complaining of back pain, bilateral hip and leg pain which radiated into patient¿s feet.Assessment: 1.Lumbar degenerative disc disease.2.Post laminectomy pain syndrome of the lumbar spine.3.Lumbar spondylosis.4.Lumbar facet arthropathy.S.Bilateral greater trochanteric bursitis right side being worse than left side.(b)(6) 2013: the patient was admitted to the facility for some tests analysis.Assessment: other malaise and fatigue, unspecified infective, otitis external.(b)(6) 2015, (b)(6) 2014: the patient was admitted to the facility for some tests.(b)(6) 2015: the patient was admitted to the facility for some tests.Assessment: proteinuria.(b)(6) 2015: the patient was admitted to the facility for some tests.Assessment: unspecified cardiovascular disease, diabetes mellitus without mention of complication, type ii or unspecified type, uncontrolled, mixed hyperlipidemia, essential hypertension, and vitamin d deficiency.
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Manufacturer Narrative
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Additional information.
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Event Description
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It was reported that on, (b)(6) 2008: patient underwent gxt myocardial perfusion imaging.Impression: abnormal myocardial perfusion spect imaging after adequate exercise.Evidence for anterior lateral scar.Normal lv function.(b)(6) 2009: patient underwent gxt myocardial perfusion imaging.Impression: abnormal myocardial perfusion spect imaging after poor exercise.Evidence for mild ischemia and anterior apical scar.Abnormal lv function.(b)(6) 2011: patient underwent the following procedures: 1.Left heart catheterization.2.Left ventriculography.3.Coronary angiography.4.Internal mammary artery graft angiography.5.Saphenous vein graft angiography.Impression: 1.Three-vessel coronary artery disease.2.Three patent bypass grafts.3.Significant stenosis in the saphenous vein bypass graft to the obtuse marginal branch of the left circumflex coronary artery.4.Successful catheter-based intervention.A) placement of two xience drug-eluting stents in the saphenous vein bypass graft to the obtuse marginal branch of the left circumflex coronary artery.B) this was guided by intravascular ultrasound interrogation.5.Segmental wall motion abnormalities with mildly diminished left ventricular systolic function.(b)(6) 2011: patient presented with following impression: 1) three vessel coronary artery disease.2) patent stent in the saphenous vein graft to the obtuse marginal branch.3) impaired left ventricular systolic function.(b)(6) 2012: patient underwent myocardial perfusion imaging.Impression: myocardial perfusion imaging is abnormal.Overall left ventricular systolic function is abnormal with regional wall motion abnormalities.(b)(6) 2014: patient presented with following assessment.1) diabetes mellitus without mention of complication type 2 or unspecified type, uncontrolled, essential hypertension benign, lumbago, unspecified cardiovascular disease, osteoarthrosis involving multiple sites but not specified as generalized, unspecified vit d deficiency.(b)(6) 2015: patient presented with candidiasis of unspecified site.(b)(6) 2015: patient presented with following assessments: deiabetes mellitus without complications, lumbago, atherosclerotic heart disease of native coronary artery without angina pectoris, mixed hyperlipidemia, hypertension, osteoarthritis, testicular hypfunction, insomnia, restless legs syndrome.
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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) 2008, patient presented for cdl physical.(b)(6) 2008 <(>&<)> (b)(6) 2008 <(>&<)> (b)(6) 2008 , the patient presented in the facility for follow up and regular check up.(b)(6) 2009, the patient presented with complaint of right ear pain, facial pain maxillary, nasal congestion.Assessment : 1.Acute sinusitis , upper respiratory infection , cerumen ,coronary artery disease.(b)(6) 2013 patient presented for an office visit, impression: 1.Post laminectomy pain syndrome, 2.Lumbar radiculitis.(b)(6) 2013, (b)(6) 2014: the patient presented for a follow up with complaints of low back pain which radiates to the bilateral lower extremities and is stopping at his feet.Impression: 1.Post laminectomy pain syndrome of the lumbar spine, 2.Lumbar degenerative disc disease, 3.Lumbar spondylosis.(b)(6) 2015: patient presented due to the following: 1.Lumbar degenerative disc disease, 2.Post laminectomy pain syndrome of the lumbar spine, 3.Lumbar radiculitis.
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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 (b)(6) 2005: patient underwent stress echo study which was negative for ischemia.On (b)(6) 2006: patient underwent lower extremity arterial duplex/doppler study due to claudication.Impression: mild significant plaque is visualized in the arteries of the lower extremities bilaterally.No turbulent flow by color doppler analysis.Normal velocities of flow by spectral doppler wave form analysis.Arterial duplex examination of the lower extremities with mild plaque.Patient underwent stress echo study which was negative for ischemia.On (b)(6) 2006: patient presented with chronic lumbar pain, neck pain and soreness in both shoulders and got worse with neck movements.Patient could not sleep on the left side or right side for a long time because of shooting and pinching pain.Assessment: possible cervical djd/radiculopathy.Djd of lumbar vertebra.Obesity.Osa.(b)(6) 2006: patient presented with neck pain.Assessment: neck pain possible radiculopathy.On (b)(6) 2006: patient underwent left shoulder mri which showed spondylosis with foraminal stenosis on the left side at c6-c7, most li kely related to the patient's radiculopathy.Patient underwent left shoulder x-ray.Impression: essentially normal examination of the shoulder.On (b)(6) 2007: patient underwent gxt myocardial perfusion due to cad.Impression: abnormal stress cardiolite study.No evidence for anterior wall scar at adequate hr.No ischemia noted.Abnormal lv systolic function.Lvef: 42%.No significant ecg abnormalities.No arrhythmias.Normal bp response.Normal exercise tolerance.On (b)(6) 2007: patient presented for follow up.Impression: rheumatoid arthritis- active disease.On (b)(6) 2007: patient presented for follow up.Assessment: lumbar djd with radiculopathy; hyperkalemia.On (b)(6) 2007: patient underwent echocardiographic study due to indication of cad.On (b)(6) 2008: patient presented for follow up.Assessment: pharyngitis; hyperlipidemia.On (b)(6) 2008: patient presented for follow up.Assessment: arthritis of the right hand, exacerbation.On (b)(6) 2008: patient underwent left heart catheterization, left ventriculography, coronary angiography, left internal mammary artery graft angiography, saphenous vein graft angiography, stening of the saphenous vein bypass graft to the obtuse marginal branch of the left circumflex coronary artery and intravascular ultrasound interrogation due to coronary artery disease, silent ischemia and abnormal stress test showing ischemia.Impression: three vessel coronary artery disease.Three patent bypass grafts.Significant stenosis in the saphenous vein bypass graft to the obtuse marginal branch of the left circumflex coronary artery.Successful catheter-based intervention.Segmental wall motion abnormalities with mildly diminished left ventricular systolic function.On (b)(6) 2009: patient presented for follow up.Assessment: arthritis, cad, osa.On (b)(6) 2010: patient presented with severe back pain with movement.Assessment: anemia, elevated lft, htn, dm.On (b)(6) 2010: patient underwent chest x-ray due to shortness of air.Impression: no acute process.On (b)(6) 2010: patient underwent myocardial perfusion study due to cad.Abnormal exercise stress myocardial perfusion study demonstrated: evidence for anterior lateral scar.Abnormal left ventricular systolic function with a calculated lvef of 33% with global hypokenesis.No chest pain at maximal exercise, however the patient did experience dyspnea.Normal exercise ecg.On (b)(6) 2011: patient underwent myocardial perfusion study due to cad.Impression: myocardial perfusion imaging was abnormal.Overall left ventricular systolic function is abnormal with regional wall motion abnormalities.On (b)(6) 2012: patient presented with chronic back pain.It had been constant, sharp and aching.It was described as being severe and in the area of the lower lumbar spine and radiating to the right lower extremity and to the left lower extremity.On (b)(6) 2012: patient underwent mri of lumbar spine without contrast due to low back pain, bilateral lower extremity numbness and pain.Impression: advanced l4-l5 degenerative disc disease, with lateral recess stenosis on the right and left, and relatively mild foraminal narrowing.Only border line canal stenosis.Milder degenerative changes elsewhere by disc level.Patient also underwent lumbar spine x-ray.Impression: degenerative changes are seen within the spine with no evidence of fracture or malalignment.On (b)(6) 2012: patient presented with intractable low back pain with radiation to the bilateral legs, which has progressed/persisted and been unresponsive to narcotic analgesics.Patient underwent following procedures: fluoroscopic-guided l4/l5 disc injection and discography.Fluoroscopic-guided l5/s1 disc injection and discography.No complications reported.Impression: again noted are six, non-rib-bearing, lumbar-type vertebrae; the last, non-rib-bearing vertebra is designated s1 for purpose of this dictation.The l4/l5 and l5/s1 disc spaces are abnormal with fluoroscopy, demonstrating degenerative discs and at least an annular tear at the l5/s1 level.Patient underwent ct of the lumbar without contrast due to degenerative disc disease.Impression: discogram demonstrating moderate degenerative disc disease at l3-l4 classified as modified dallas score 4.There is moderate to severe degenerative disc disease at l4-l5 with extravasation of discogram contrast into the lateral foramina on the right and left consistent with high-grade annular tear; modified dallas score 4/5.On (b)(6) 2012: patient presented with neurogenic claudication.Impression: degenerative disc disease/spinal stenosis.On (b)(6) 2012: patient underwent chest x-ray due to hypertension.Impression: no active disease.On (b)(6) 2012: patient presented with back and bilateral leg pain.Impression: degenerative disc disease l4-5/l5-s1.Pre-op diagnoses: spinal stenosis l3-4, l4-5.Segmental instability with acquired spondylolisthesis l3-4 and l4-5.Patient underwent posterior lumbar interbody fusion l3-l5 with pedicle screw fixation l3-l5 using stealth technology and the o-ring.Procedure was carried out under fluoroscopy.Surgical findings included marked thickening of the ligamentum flavum which actually constricted the dural cylinder, particularly at l3-l4 and l4-l5.Per op notes, in the l4-l5 interspace, a 10x22 mm peek cage into which autologous bone had been placed was placed into the disc space and countersunk approximately 3 to 4 mm.A tlif was performed at l3-l4.A 12 x 26 mm peek cage with bmp and autologous bone was countersunk and advanced across the midline.A ct scan was performed.2 5.5 x 50 mm screws were placed at l3, 6.5 x 50 mm screw was placed in l4 and a 5.5 x 40 mm and one 6.5 x 50 was placed in l5.These were then attached with the peek rod which measured 60mm.Post fluoroscopy showed good decompression and alignment.No complications reported.On (b)(6) 2012: patient was discharged to home with discharge diagnosis of diabetes, copd, spinal stenosis secondary to acquired spondylolisthesis at l3-l4 and l4-l5.On (b)(6) 2013: patient underwent lumbar spine x-ray due to spondylolisthesis.Findings: the appliances were perfectly positioned and there was no fracture of the hardware.Also, there was a mild anterolisthesis of l4 from l5 which appears stable from previous imagin g.There was no evidence of continued subluxation, fracture, erosion or acute abnormality superimposed upon stable postsurgical findings.On (b)(6) 2013: patient presented for follow up with back pain.Patient underwent lumbar spine x-ray.Findings: although there was osteophyte formation and degeneration from l3 through l5, there was no subluxation and no change in the overall alignment or appearance when compared to (b)(6) 2013 images.Also, there was no fracture of the hardware and therefore no significant interval finding or significant change was identified.On (b)(6) 2013: patient presented with back pain.On (b)(6) 2013: patient presented with back pain and reported a radicular component into both lower extremities at this time mainly on the right but involving both lower extremities all the way down to the feet.Patient reported pain being greatly incapacitating and interfered with activities of daily living and made it very difficult for him to sleep at night.Impression: post-laminectomy pain syndrome; lumbar radiculitis.On (b)(6) 2013: patient underwent lumbar spine x-ray due to spondylolisthesis.Findings: bilateral pedicle screws and posterior fusion rods were present at l3, l4 and l5.Intervertebral bone grafts were present at l3-4 and l4-5.The abdominal aorta was heavily calci fied.The hardware was intact.There were no areas of osteolysis to suggest loosening.Laminectomy changes were present at l3, l4 and l5.There had been no significant change since (b)(6) 2013, (b)(6) 2014, (b)(6) 2015: patient presented for follow up on diabetes, hyperlipidemia, hypertension and generalized anxiety disorder and joint stiffness.Assessment: diabetes mellitus without mention of complication, type ii or unspecified type, uncontrolled; essential hypertension, benign; lumbago; unspecified cardiovascular disease; osteoarthritis involving multiple sites, but not specified as generalized; unspecified vit-d deficiency; other testicular hypo function; anxiety state, unspecified; depressive disorder, not elsewhere classified; mixed hyperlipidemia; allergic rhinitis, cause unspecified.On (b)(6) 2013: patient presented being sick and with scratchy throat, running nose and non-productive cough.Assessment: unspecified vit-d deficiency; other testicular hypofunction; acute upper respiratory infections of unspecified sites.On (b)(6) 2013, (b)(6) 2014: patient presented with low back pain and bilateral lower extremity pain.Assessment: lumbar degenerative disc disease; lumbar radiculitis; lumbar spondylosis.On (b)(6) 2014: patient underwent myocardial perfusion study due to cad.Impression: myocardial perfusion imaging was abnormal.Overall left ventricular systolic function was abnormal with regional wall motion abnormalities.On (b)(6) 2014: patient underwent ct lumbar spine due to bilateral leg pain greater on the right, right foot numbness.Impression: transitional vertebra at s1 with false joint on the left and arhtropathic changes in the false joint.Mild canal stenosis at l3-4.Post-operative changes at l4-5 with posterior end plate spurring on the left and moderate foraminal stenosis on the left.Post-operative changes at l5-s1 with posterior end plate spurring and moderate foraminal stenosis on the right.Mild arthropathic changes in both sacroiliac joints.Atheroscerotic calcification in the abdominal aorta and origin of the superior mesenteric artery.On (b)(6) 2015: patient presented for follow up on diabetes, hyperlipidemia, hypertension and generalized anxiety disorder and joint stiffness.Assessment: diabetes mellitus without mention of complication, type ii or unspecified type, uncontrolled.On (b)(6) 2007: patient underwent left hand x-ray due to pain and swelling.Impression: mild soft tissue swelling about the second and third fingers, study otherwise essentially normal.Patient also underwent right hand x-ray due to pain.Impression: prior healed fracture of the distal phalanx of thumb finger.Study otherwise within normal limits and negative for significant arthritic changes.Patient also underwent left foot x-ray due to pain.Impression: osteophytes involving the os calcis with heel spur, study otherwise negative.Patient also underwent right foot x-ray due to pain.Impression: degenerative arthritis changes involving the first metatarsophalangeal joint with hypertrophic spurring and mild soft tissue swelling over the dorsum of the foot and osteophyte involving the posterior aspect of the os calcis, study otherwise within normal limits.On (b)(6) 2011: patient underwent mri lumbar spine without contrast which revealed ddd with bulging disc and facet hypertrophy at l3-4; severe ddd with bulging disc and facet hypertrophic changes with canal stenosis and bilateral nfn at l4-5.On (b)(6) 2012: patient presented with low back pain going down both legs.Pain was described as aching and burning.Assessment: chronic pain syndrome; spinal stenosis: lumbar region, without neurogenic claudication; radiculopathy, lumbar; spondylosis; lumbosacral w/o myelopathy; degeneration of lumbar or lumbosacral intervertebral disc.On (b)(6) 2012: patient presented with low back pain going down both legs.Patient underwent therapeutic epidural steroid injection, bilateral transforaminal approach with fluoroscopy level l4-l5.No complications reported.Assessment: radiculopathy, lumbar; spinal stenosis: lumbar region, without neurogenic claudication; chronic pain syndrome.On (b)(6) 2012: patient presented with low back and leg pain.Low back pain was at the lumbar region in the midline and this was recurring problem.Pain was described as aching and burning sensation.Musculoskeletal review revealed back pain and stiffness in joints.Patient underwent therapeutic epidural steroid injection, bilateral transforaminal approach with fluoroscopy level l4-l5.No complications reported.Assessment: radiculopathy, lumbar; spinal stenosis: lumbar region, without neurogenic claudication; chronic pain syndrome.On (b)(6) 2012: patient presented with low back and leg pain.Low back pain was at lumbar region of the back in the midline; and sacral region in the midline.Pain was described as aching and burning sensation.Musculoskeletal review revealed back pain and stiffness in joints.Patient underwent bilateral therapeutic sacroiliac injection w/fluoroscopy.No complications reported.Assessment: si joint segmental instability; chronic pain syndrome.On (b)(6) 2012: patient presented with low back and leg pain.Low back pain was at lumbar region of the back in the midline; and sacral region in the midline.Pain was described as aching and burning sensation.Musculoskeletal review revealed back pain and stiffness in joints.Assessment: si joint segmental instability; chronic pain syndrome; spondylosis, lumbosacral w/o myelopathy; degeneration of lumbar or lumbosacral intervertebral disc; spinal stenosis: lumbar region, without neurogenic claudication.On (b)(6) 2013: patient presented for re-evaluation of back pain with leg pain.On (b)(6) 2013, (b)(6) 2014: the patient presented for a follow up.On (b)(6) 2014: the patient underwent ct of brain w/o.Impression: a tiny linear petechial hemorrhage was seen along the lateral aspect of the left sylvian fissure.There was evolving low attenuation ischemic insult and infarct in the gray and white matter of the mid and posterior left parietal region.There was also evidence of an old ischemic injury along the left parietal convexity with focal areas of cortical gray matter volume loss.There was no evidence of high grade intra axial or extracerebral hemorrhage otherwise and there was no midline shift or mass effect.Incidental note was made of acute sinusitis in the right maxillary sinus.On (b)(6) 2014, (b)(6) 2015: the patient presented fro a follow up.On (b)(6) 2015: the patient presented for a follow up.
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that on (b)(6) 2012 the patient underwent a transforaminal lumbar interbody fusion ("tlif') at l3-l4 and l4-l5.First, a laminectomy of l3 and l4 was performed.Then a discectomy was performed at l4-l5 and l3-l4.A 10x22mm polyetheretherketone (peek") cage with autologous bone was placed into the disc space at l4-l5.A 12x26mm peek cage with bmp and autologous bone was countersunk into the disk space at l3-l4.A pedicle screw fixation was also performed at l3 to l5.This fusion was from a posterior approach.Reportedly, after the surgery, the patient experienced significant unwanted bony overgrowth, encroaching on his neuro-foramen and causing him significant, progressive pain.On (b)(6) 2013 patient presented for test injection only.On (b)(6) 2013 patient presented for an office visit due to medication change, want cymbalta changed to iexapro, want labs if it's time.
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Manufacturer Narrative
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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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