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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET

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MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT; FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET Back to Search Results
Catalog Number 7510800
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Syncope (1610); Apnea (1720); Asthma (1726); Atherosclerosis (1728); Bronchitis (1752); Chest Pain (1776); Dysphagia/ Odynophagia (1815); Dyspnea (1816); Fatigue (1849); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Neuropathy (1983); Pain (1994); Pneumonia (2011); Swelling (2091); Tachycardia (2095); Weakness (2145); Burning Sensation (2146); Tingling (2171); Dizziness (2194); Depression (2361); Numbness (2415); Neck Pain (2433); Palpitations (2467)
Event Type  Injury  
Event Description
"it was reported that on (b)(6) 2004, the patient presented to the operating room at hospital for lumbar fusion surgery at l4-l5 and l5-s1, where his surgeon performed a posterior lumbar interbody fusion at l5-s1 using a resorbable fusion cage packed with rhbmp-2/acs.The surgeon also performed a posterior lumbar fusion ("plf") at l4-l5 using rhbmp-2/acs.Bmp2 was also placed in the intradiscal space prior to the placement of the cage as well as on both sides after placement of the cage.Following surgery, the patient followed up with his physician.He began to develop radiating pain in his lower extremities.The patient has never recovered from his surgery, and continues to experience daily, disabling pain that prevents him from performing many basic activities of daily living.".
 
Manufacturer Narrative
(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.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that (b)(6) 1999: the patient presented for an office visit with history of substernal pressure and heart rate upto 180 to 190.(b)(6) 2000: the patient presented for a follow up on hypertension.On (b)(6) 2001: the patient presented for a follow up.Assessment: chronic back pain, copd, htn.On (b)(6) 2001: the patient presented with back pain radiating into right leg.Musculoskeletal review indicates tenderness over the lumbar area and paravertebral muscles.The right lower extremity shows mild ankle swelling.Assessment: the patient will be discharged with a diagnosis of exacerbation of chronic back pain.On (b)(6) 2001:the patient presented for a follow up.Assessment: psvt, copd, htn.On (b)(6) 2001: the patient presented for a follow up.Assessment: bronchitis, benign hypertension.On (b)(6) 2002: the patient presented for a follow up.Assessment: history of svt, probable angina, copd, chronic back pain.On (b)(6) 2002: the patient underwent electrocardiogram.Borderline abnormal changes possibly due to myocardial ischemia.On (b)(6) 2002: the patient presented with the following diagnosis: lumbar radiculopathy.On (b)(6) 2002: the patient presented for a follow up.Assessment: benign hypertension, copd, hypercholesterolemia.On (b)(6) 2002: the patient underwent x-ray of right foot due to plantar fasciitis.Impression: small plantar calcaneal spur.On (b)(6) 2003, (b)(6) 2004: the patient presented for a follow up.The patient complained of lower back pain, burning sensation in feet, feelings of something moving in back post-surgery.On (b)(6) 2003: the patient presented with the following pre-op diagnosis: chronic refractory lower back pain.Lower extremity radiculopathy.Paresthesias.Lumbar spondylosis.Refractory pain to conservative treatment.The patient underwent the following procedure: lumbar epidural asteroid injection.The patient tolerated the procedure well.On (b)(6) 2003 the patient presented with the following pre-op diagnosis: refractory lower back pain.Lower extremity radiculitis and paresthesias.Lumbar spondylosis.The patient underwent the following procedure: lumbar epidural asteroid injections.The patient tolerated the procedure well.On (b)(6) 2003 the patient presented the following pre-op diagnosis: chronic refractory lower back pain.Right lumbar facet syndrome.Refractory pain to conservative treatment.The patient underwent the following procedure: right lumbar facet joint injection with local anesthetic and steroid under fluoroscopic guidance.Patient tolerated the procedure well.On (b)(6) 2003: the patient presented for evaluation.He states he has some burning in his feet.Assessment: benign hypertension, out of medicine.History of psvt with no further chest pains.Chronic back pain with peripheral neuropathy.Impaired fasting glucose.Bronchitis.On (b)(6) 2003: the patient presented with follow up on back pain.Assessment: impaired fasting glucose.Benign hypertension.Chest pain.The patient underwent x-ray of chest.Impression: stable chest without evidence of acute cardiopulmonary disease.Interstitial fibrosis left lower lung zone with interval development of mild streaky density in the left mid lung zone related to discoid atelectasis or interstitial fibrosis.On (b)(6) 2003: the patient underwent x-ray of chest with contrast.Impression: small nonspecific infiltrate in the lingula.No pulmonary nodules or mass lesions identified.The patient underwent ct chest with contrast due to abnormal chest.Impression: small non-specific infiltrate in the lingual.No pulmonary nodules or mass lesions identified.On (b)(6) 2003: the patient underwent x-ray of chest.Assessment: abnormal chest x-ray.On (b)(6) 2003 the patient presented with following admitting diagnosis: back pain.On (b)(6) 2003: the patient underwent x-ray of chest.Impression: no evidence of acute cardiopulmonary disease.There is mild interval increase in the degree of subsegmental atelectasis in the lingula segments of the left upper lobe.These changes are superimposed upon mild interstitial fibrosis.On (b)(6) 2003: the patient presented with back pain.Impression: chronic mechanical low back pain syndrome.On (b)(6) 2004 the patient presented with following admitting diagnosis: black lung determination.On (b)(6) 2004: the patient presented with low back pain and leg and foot pain.Impression: l5 spondylolysis with grade-1 l5/s1 spondylolisthesis.The patient has stenosis at l4/5 and l5/s1.On (b)(6) 2004 the patient underwent ct lumbar spine w/o contrast due to l5 defect.Impression: l5 bilateral spondylolysis with grade i spondylolisthesis and some bulging disks that mildly stenose the l4-l5 canal.On (b)(6) 2004: the patient presented for a pre-op exam for the back surgery.Right lower back pain.The patient underwent x-ray of chest.Impression: no evidence of acute cardiopulmonary disease.There has been interval re-expansion of the subsegmental atelectasis at the left lung base.On (b)(6) 2004: the patient presented with severe low back pain.Impression: l5 spondylolysis with grade-1 l5/s1 spondylolisthesis.There is spinal stenosis at both l4/5 and l5/s1.There is degenerative disc disease at both l4/5 and particularly l5/s1.On (b)(6)2004: the patient presented with back and leg pain, long history of back pain in the lumbosaral region.Preoperative diagnoses: ls spondylolysis with grade i l5/s1 spondylolisthesis and l5/s1 stenosis.L4/5 and l5/s1 segmental instability.Procedures: l4/5 and l5/s1 decompressive laminectomies and bilateral facetectomies.L4 to s1 segmental posterior fusion with tsrh-3d pedicle screw fixation and autologous bone graft.Right posterior iliac crest bone graft harvesting.Local bone autograft harvesting.Per-op notes: hemostatis was obtained.There was total disruption of the inner spinous ligaments at l4/5.There was marked hypermobility of l4 on l5.The l5 lamina was free floating.The muscle was dissected laterally to expose the transverse processes at l4 and l5 and the ala of the sacrum.Next, soft tissue was cleared from the spinous process lamina at l4 and l5.Total laminectomy at l5 and a partial laminectomy at l4 was performed.All of the bone dust was mixed with luekens trap.This was mixed with 2 oz of cancellous allograft and the iliac crest autograft.This morsellized bone was mixed for the grafting.The medial aspect of the l4/ 5 facets were removed to decompress the origin of the l5 nerve roots.Then, the l5 nerve roots were followed through the neural foramen.The l5 roots were completely decompressed.Once the dura and nerve roots were decompressed, they were covered with gelfoam.At s1, pedicle screws were tapped to 6.5mm.At l4 and l5, 7.5mm taps were used.Next, the transverse processes and lateral facets were decorticated.Then, the morsellized bone graft was placed in the lateral transverse process spaces.A 5.5 mm diameter rod was cut and contoured and attached to the pedicle screws.These were then appropriately tightened.A cross link was placed between the l5 and s1 pedicle screws.The rest of the bone graft was placed around the pedicle screws.Fat graft and gelfoam were placed in the epidural space.The patient was discharged on (b)(6) 2004.On (b)(6) 2004: the patient presented for a follow up.Doing well.On (b)(6) 2004: the patient presented with chronic low back pain.Hyperglycemia, yearly screening.The patient underwent x-ray of lumbar spine.Impression: sip laminectomy at l5 with posterior spinal fusion at l4, l5 and s1.There are pared pedicle screws in place at each level.Both pedicles screws at s1 appear to be fractured.Mild lumbar spondylosis with moderate degenerative disk disease at l5/s1.Grade i spondylolisthesis of l5 on s1 and grade i retrolisthesis of l4 on l5.No evidence of acute fracture, dislocation or other osseous abnormalities.On (b)(6) 2004: the patient presented with severe back pain.Broken s1 screw.On (b)(6) 2004: the patient presented with back pain.On (b)(6) 2004: the patient presented with recurrent low back pain.The patient underwent ct lumbar spine w/o contrast due to s/p l4 to l5 post fusion, low back pain.Impression: laminectomy at the level of l5 with posterior fusion by means of surgical screws and bars at the l4, l5 and s1 levels.There is mild grade i spondylolisthesis at the level of l5.Mild disk bulge is noted at l4-5 disk level.There is a degenerative disk at the l5-s1 disk level with loss of disk height, a vacuum disk phenomena and moderate sized posterior degenerative spur arising from the inferior end-plate of vertebral body l5.The rest of the examination is unremarkable.On (b)(6) 2004: the patient presented with lumbar disc disease.The patient underwent x-ray of lumbar spine.Findings: soft tissue retractors are seen.Pedicle screws and fixation rods are seen at l4, l5, s1.Vertical alignment appears within normal limits.On (b)(6) 2004: the patient presented with back pain.He had a past decompressive laminectomy and posterior fusion with pedicle screw fixation from l4 to s1 on (b)(6) 2004.The patient underwent x-ray which showed fractured s1 pedicle screw.Impression: l5-s1 instability with sacral screw fracture.Pre-op diagnosis: l5-s2 degenerative instability status post s1 pedicle screw fracture.Procedures: removal of broken s1 pedicle screw.L5-s1 transforaminal interbody fusion with peek cage and bone growth factor.L4 to s1 segmental posterior fusion with pedicle screw fixation and lateral transverse process bone graft.Single incision, 360 degree posterior spine fusion.Per-op notes: the muscle was dissected laterally to expose the instrumentation from l4 to s1.The broken pedicle screw at s1 was removed.No patient complications were reported.On the left side, the pedicle screw was a 6.5 mm trumpet.It was replaced with a 7.5 mm screw.On the right side, the bone graft at the l5-s1 level was removed.A radical diskectomy was accomplished.The pedicle screws on the left side were tightened to maintain distraction.The disk space was then again cleared.Next, cancellous allograft was placed in the disk and pushed to the left side.This was packed with rh-bmp2/acs soaked sponge.A layered graft of allograft and rh-bmp2/acs sponge and then more allograft was applied and pushed to the left side.Then an 8 x 26 mm peek cage was filled with rh-bmp2/acs soaked sponge and passed into the disk space.It was set flush with the posterior aspect of the s1 vertebral body.Next, more bone graft and rh-bmp2/acs soaked sponge was placed laterally on both sides.Then the 7.5 mm x 45 mm pedicle screw was placed on the right at s1.The 5.5 mm diameter rod was then connected to the pedicle screws and the l4 and l5 pedicle screws were tightened.Then compression was obtained across the disk space between t5 and s1 on both sides.On (b)(6) 2004: the patient presented with complaints of pinched nerve, low back pain.The patient has pain over the lower ls-spine, radiating to his right sacroiliac area and down his right lower extremity over the posterior aspect.The pain is associated with numbness of his toes.Physical examination of back shows mild tenderness to palpation of the lower ls-spine and right sacroiliac area.Impression: exacerbation of chronic low back pain status post spinal fusion, rule out radiculopathy.The patient underwent x-ray of lumbar spine ((b)(6) 1988).Impression: stable appearing posterior fusion at the level of l4, l5 and s1 and grade 1 spondylolisthesis at the level of l5.On (b)(6) 2004: the patient presented for a follow up.On (b)(6) 2004 the patient underwent x-ray of lumbar spine 2 or 3 views due to s/p l5-s1 fusion.Impression: lumbosacral internal fixation.On (b)(6) 2004 the patient presented with complaints of pain in chest area, flutter and palpitation sensation, shortness of air and racing heart.The patient underwent chest x-ray single view due to chest pain.Assessment: normal sinus rhythm.Impression: shallow inspiration versus prominent fat pads or bibasal atelectasis.On (b)(6) 2005 the patient came for an office visit with complaints of chest pain, shortness of air, syncope.The principal diagnosis was: cardiac dysrhythmias.As per medical records, the musculoskeletal review of indicates joint pain-back problems.The neurological review indicates syncope-focal weakness ha-sz-dizziness.Impressions: junctional supraventricular tachycardia, resolved.Cheat pain.(b)(6) 2005: the patient presented with painful paresthesias in both feet in shocking distribution.The patient underwent mri.He has some degeneration of the disc above the fusion at l3-l4.There is no spondylolisthesis or central stenosis.On (b)(6) 2005: the patient presented for a follow up.Assessment: hypertension, chronic back pain, yearly screening.The patient complains of posterior neck pain.The patient underwent x-ray.Impression: normal cervical spine.On (b)(6) 2005: the patient presented for office visit.Assessment: hypertension, hyperlipidemia, history of angina.On (b)(6) 2005 the patient was diagnosed for chronic back pain.On (b)(6) 2006 the patient underwent x-ray of lumbosacral spine region due to lumbago.Impression: the patient is status post previous fusion procedure.No significant change from (b)(6) 2004.On (b)(6) 2006 the patient was diagnosed for chronic back pain.On (b)(6) 2006: the patient presented for office visit.Assessment: copd, chronic back pain, hypertension, diabetes, erectile dysfunction.On (b)(6) 2006: the patient presented for a follow up.Assessment: hypertension, type 2 diabetes controlled, copd (b)(6) 2006 the patient presented with admitting diagnosis of fbl.On (b)(6) 2005, (b)(6) 2006: the patient presented for a follow up.Assessment: hypertension, type 2 diabetes controlled, copd, ed.On (b)(6) 2006: the patient presented for a follow up.Assessment: hypertension, type 2 diabetes.On (b)(6) 2007: the patient presented with pneumoconiosis.He underwent chest x-ray for black lung.Conclusion: left lower lung zone atelectasis.Occasionally this can be a manifestation of a centrally obstructing neoplasm.Hazy densities in the right cardiophrenic angle and left costophrenic angle, likely fat deposition.On (b)(6) 2007: the patient presented for a follow up.Assessment: hypertension, type 2 diabetes, copd.On (b)(6) 2007: the patient underwent ct of chest with contrast due to atelectasis iii.Impression: there is some coarse linear infiltrate in the lingula.This may represent scar or atelectasis.No mass lesions are seen.No evidence of pneumoconiosis.The patient underwent ct thorax w/o contrast.On on (b)(6) 2007: the patient presented for a follow up.Assessment: hypertension, type 2 diabetes, copd, chronic back pain, ed.On (b)(6) 2007: the patient presented with bilateral leg parasthesias, status post spinal cord stimulator trial.Impression: post laminectomy syndrome, lumbar, with recent successful spinal cord stimulator trial.On (b)(6) 2007: the patient resented with pre-op diagnosis: post laminectomy syndrome, status post spinal cord stimulator trial.Procedure: placement of permanent spinal cord stimulator and battery generator.Per-op notes: the spinous processes and lamina were taken down at t8 and t9.The spinous processes was removed exposing the ligamentum flavum and a small laminotomy was performed.The electrode was then slipped underneath the lamina.A laminectomy was then performed underneath the inferior lamina.Again, the stimulator was placed.The battery generator was placed into the subcutaneous pocket.The patient underwent c-arm fluoroscopy.The level of the stimulator was marked as t8 on the image.On (b)(6) 2007: the patient presented for a follow up.Doing well after surgery.On (b)(6) 2007: the patient presented for office visit.Assessment: copd, chronic back pain, hypertension, , diabetes, erectile dysfunction.On (b)(6) 2008: the patient underwent x-ray of chest.Impression: a small infiltrate probably chronic left lower lobe along with linear plate like atelectasis.The patient underwent x-ray of ribs.Impression: normal.The patient underwent x-ray of abdomen.Impression: the abnormality is a pleural reaction above the left hemidiaphragm, small linear atelectasis and a small patchy infiltrate in the left lower hemithorax.On (b)(6) 2008 the patient underwent chest x-ray due to chest pain.Impression: no active disease.On (b)(6) 2008 the patient presented with a chief complaint of chest pain and pain in the lower retrosternal region and epigastric region.Musculoskeletal review indicated history of back pain.Neurological review indicates that patient suffers frequent loss of sensation associated with numbness and tingling in both of his feet.Impression: chest pain and epigastric pain, etiology to be determined.Multiple risk factors for coronary artery disease.Dysphagia.Assessment: uncontrolled diabetes several morbid conditions including hypertension, copd, supraventricular tachycardia, gerd and chronic pain.On (b)(6) 2008 the patient underwent radiology tests of upper gi w/ and w/o air contrast and kub.Diagnosis: dysphagia.On (b)(6) 2008 the came for an office visit due to shortness of air, chest tightness, fever and cough.The patient also presented with back pain, leg pain and burning sensation on both feet.The person was diagnosed with pneumonia.The secondary diagnosis was copd exacerbation.On (b)(6) 2008 the patient came for an office visit due to chest pain and was diagnosed for chest pain, abdominal pain, dysphagia, hypertension, lumbago, asthma, morbid obesity and hyperlipidemia.On (b)(6) 2008 the patient came for an office visit due to shortness of air, chest tightness, fever and cough.The patient also presented with back pain, leg pain and burning sensation on both feet.The person was diagnosed with pneumonia.The secondary diagnosis was copd exacerbation, acute renal failure and diabetes mellitus, type 2.On (b)(6) 2008 the patient underwent x-ray of chest due to shortness of air.Impression: no active disease.On (b)(6) 2008: the patient got admitted to hospital.On (b)(6) 2008: the patient underwent for pain management.On (b)(6) 2008 the patient came for an office visit and was diagnosed for pneumonia, acute renal failure, obesity, leukocytosis, neuropathy in diabetes, cardiac dysrhythmias.On (b)(6) 2008: the patient got admitted with diagnoses of low back pain, joint pain, headache, fatigue.Patient also underwent hematology and urinalysis test.On (b)(6) 2008: the patient presented with complaint of low back pain.For which patient underwent ct of lumbar spine.Impressions: degenerative disk disease with postsurgical changes and scoliosis.On (b)(6)2009: the patient presented with weakness, fatigue, short of breath, occasional chest pain.Assessment: dyspnea/probable angina, episodes of svt, peripheral neuropathy, type 2 diabetes, fatigue.On (b)(6) 2009 the patient presented with complaints of recurrent chest pain, shortness of air, weakness, palpitations and swelling in ankles feet or legs and hands.Musculoskeletal review indicates generalized muscle aches and pains.Back pain.Impression: precordial chest pain consistent with angina.Hypertensive heart disease.Diabetes mellitus with complications.Peripheral vascular disease.Chronic obstructive pulmonary disease.On (b)(6) 2009 the patient presented with chief complaint of chest pain, heart palpitation for which patient underwent ecg, hematology and x-ray of chest.Impression: chronic stable linear parenchymal scar in the left lower lung.No active disease was noted.Tachycardia with palpitations.Chronic low back pain.Abnormal cardiolite cardiac stress test.Chest pain consistent with angina.Atherosclerotic heart disease.Hypertensive heart disease.Dyslipidemia.Diabetes mellitus type 2, insulin poorly controlled with diabetic neuropathy.Chronic tobacco use.Progressive dyspnea with chronic obstructive pulmonary disease.On (b)(6) 2009 the patient presented with admitting diagnosis of chest pain.The secondary diagnosis was: neuropathy in diabetes, cardiac dysrhythmias, sleep apnea, lumbago, hyperlipidemia, atrial fibrillation, aortic atherosclerosis.The patient underwent the following procedure: primary stenting of the right coronary artery.Left heart catheterization.Left ventricular angiogram.Coronary arteriogram.Abdominal aortogram.No complication noted.On (b)(6) 2009 the patient presented with chest pain.The patient underwent myocardial perfusion imaging after sestamibi.Post stress tomographic imaging.Impression: there appears to be a small partly reversible inferior perfusion defect which should be correlated with clinical data.On (b)(6) 2009: the patient underwent left heart catheterization, left ventriculogram, rca and lca angio, s&i pulmonary/select, s&i vent/angio, abdominal aortogram.On (b)(6) 2009: the patient got discharged with discharge diagnosis of: coronary heart disease, status post cardiac stent placement.Acute bronchitis.Probable sleep apnea.On (b)(6) 2009: the patient presented with complaint of obstructive sleep apnea.Impression: mild obstructive sleep apnea.On (b)(6) 2009: the patient presented for a follow up on coronary artery disease and anxiety.On (b)(6) 2009 the patient came for a follow-up and was diagnosed for hypertensive heart disease, shortness of breath.Impression: hypertensive heart disease.Diabetes mellitus type 2.On (b)(6) 2009 the patient presented with admitting diagnosis obstructive sleep apnea.On (b)(6) 2009: the patient presented for a follow up on palpitations.On (b)(6) 2009: the patient presented for a follow up on orthostasis, copd.On (b)(6) 2009: the patient presented for a follow up on orthostasis.Assessment: orthostasis, urticaria.On (b)(6)2010: the patient presented for a follow up on type 2 diabetes and copd.On (b)(6) 2010: the patient was admitted to the emergency room with left-sided chest pressure and pain and palpitations.The patient also experienced numbness of the left arm.Patient underwent various chemical tests, radiological studies, non-invasive mech vent and a thallium stress test, which showed a fixed inferior wall defect, but no reversible ischemia.The impression of the chest x-ray was as follows: impression: left basilar scarring without evidence of acute cardiopulmonary disease.Patient¿s review of systems indicated: positive for chest pain.Positive for palpitations.Positive for shortness of breath.Positive for nausea.The following were the impression of the overall study: chest pain.Coronary artery disease.Status post stenting of the right coronary artery.On (b)(6) 2010: the patient presented with complaints of chest pain and underwent stress test.The following were the impression: myocardial perfusion study does not reveal any stress induced reversible myocardial perfusion defects.A small mild fixed inferior perfusion defect likely represents diaphragmatic attenuation artifact and clinical correlation is recommended.The computer-derived estimated ejection fraction is 49%.On (b)(6) 2010: the patient presented with complaints of chest pain and underwent echocardiography study.The patient was discharged to home.On (b)(6) 2010: the patient presented for a follow up on coronary artery disease, hospitalization of chest pain.Assessment: type 2 diabetes fairly controlled, hyper lipidemia, anxiety disorder.On (b)(6) 2009, (b)(6) 2010: the patient presented for a follow up on cough, congestion, wheezing.Assessment: copd exacerbation.On (b)(6) 2010: the patient presented for a follow up on cough, congestion, rhinorrhea.Assessment: acute exacerbation.02/25/2011: the patient presented for a follow up.(b)(6) 2011: the patient presented for a follow up on type 2 diabetes, hyper lipidemia.On (b)(6) 2011: the patient presented for an office visit.On (b)(6) 2011: the patient presented for an office visit.Diagnosis: neuropathy, neuralgia, neuritis and radiculitis, obesity, diabetes mellitus, benign hypertension, hyperlipidemia, coronary atherosclerosis, esophageal reflux, need for prophylactic vaccination and inoculation against streptococcus pneumonia, , need for prophylactic vaccination and inoculation against influenza.On (b)(6) 2011: the patient presented for a follow up on type 2 diabetes, depression.On (b)(6) 2011, (b)(6) 2012: the patient presented for an office visit.Diagnosis: neuropathy, neuralgia, neuritis and radiculitis, obesity, diabetes mellitus, benign hypertension, hyperlipidemia, coronary atherosclerosis, esophageal reflux, disc displacement lumbar, special screening examination of malignant neoplasm of colon, on (b)(6) 2012: the patient underwent ct scan of lumbosacral spine w/o contrast, due to low back pain.Study indicated ¿impression: patient is status post fusion procedure with first degree anterior spondylolisthesis of l5 onto s1.No change is seen compared to the pr evious exams.There is mild diffuse degenerative change present.On (b)(6) 2012: the patient presented with lumbago and underwent radiological studies for the diagnosis of lumbosacral spondylosis and s pondylolisthesis.On (b)(6) 2012: the patient presented with complaints of knee pain and underwent x-ray of right knee (3 views).The impression of the x-rays was as follows: probable bipartite patella.No definite fracture.(b)(6) 2012: the patient presented for a follow up on type 2 diabetes, depression.Assessment: type 2 diabetes, depression worsening.On (b)(6) 2012: the patient presented for a follow up on type 2 diabetes.On (b)(6) 2012: the patient presented for a follow up on type 2 diabetes and hypertension.Assessment: type 2 diabetes and hypertension, right knee pain.11/08/2012: the patient presented for a follow up on right knee pain.On (b)(6) 2012: the patient underwent x-ray of right knee.Impression: probable bipartite patella.On (b)(6) 2012: the patient presented for a follow up on type 2 diabetes and copd.Assessment: type 2 diabetes, gerd, copd.On (b)(6)2013: the patient presented for a follow up on near syncopal episodes.On (b)(6) 2013: the patient presented for a follow up on orthostasis.05/17/2013: the patient was admitted with admitting diagnosis: peritonsillar abscess and chief complaints of sore throat and foreign body in larynx.He was in quite a bit of pain and his blood sugar was found to be 500.The patient was also diagnosed with streptococcus bacteremia and type 2 diabetes, poorly controlled.The patient underwent neck ct with and without contrast, which gave the following impression: suggestion of soft tissue thickening involving the supraglottic larynx.Direct visualization is recommended.Mild enlargement of the left tonsillar region with a small focus of low attenuation within the tonsil measuring up to approximately 1.1 cm in size.A small developing abscess is not excluded.Patient¿s review of systems indicated: swollen lymph nodes in his neck, numbness in his legs, chronic weakness of his legs and poor hearing.The impression of the study was a follows: tonsillar abscess.Non-insulin-dependent diabetes mellitus, insulin requiring, poorly controlled.Multiple medical problems as mentioned above.On (b)(6) 2013: the patient was discharged to home.On (b)(6) 2013: the patient presented for a follow up on tonsillitis and peri tonsillar abscess.Assessment: tonsillitis, type 2 diabetes.On (b)(6) 2013: the patient presented for a follow up on gerd.On (b)(6) 2013 the patient came for an office visit: for evaluation of blurry vision in the left > right.Iddm *15 years.Average bs> 200.Impression: diabetes mellitus type 2, uncomplicated nuclear sclerosis ou neoplasm of uncertain behavior of skin (nose) hypertensive retinopathy ou non-exudative senile macular degeneration of retina os.On (b)(6) 2013: the patient was admitted with admitting diagnosis: chest pain.The reasons for his visit were: dizziness and giddiness and skin sensation disturb.Patient underwent various chemical tests and hematology reports.The patient also underwent ct scan of the head without contrast.The exam revealed that the intracranial structures were unremarkable.No abnormal intra-axial or extra-axial lesions were appreciated.Patient¿s chest x-ray (ap upright film) revealed that the heart size was normal.Impression: findings consistent with copd.No evidence of active disease.On (b)(6) 2013: the patient was diagnosed with hypertension, hyperlipidemia and type 2 diabetes.On (b)(6) 2013 the patient came for an office visit with complaint of palpitations.Impression: no angina symptoms.Continues to have palpitations no or worse since starting bb therapy.Shortness of breath: chronic.Hypertension, reasonably well controlled.Mixed hyperlipidemia.Diabetes mellitus type 2, uncomplicated.On (b)(6) 2013: the patient was admitted with admitting diagnosis: fatigue and hypertension.Patient underwent various chemical tests and hematology reports.On (b)(6) 2014 the patient came for an office visit with complaint of coronary artery disease, hypertension.Neurological review was positive for dizziness.Impression: no angina symptoms.Continues to have palpitations no or worse since starting bb therapy.Shortness of breath: chronic.Hypertension, reasonably well controlled.Mixed hyperlipidemia.Diabetes mellitus type 2, uncomplicated.Sleep apnea.Obesity bmi>35.On (b)(6) 2014, (b)(6) 2013: the patient presented for a follow up on type 2 diabetes.On (b)(6) 2014: the patient was admitted with admitting diagnosis: obs chr bronc w (ac) exac (obstructive chronic bronchitis with (acute) exacerbation) and chief complaint of shortness of air, wheezing.Patient underwent various chemical tests and hematology reports.The patient also underwent a single view x-ray of chest for shortness of air.¿impression: mild left peripheral atelectasis.¿ on (b)(6) 2014: the patient underwent 2 views (paand lateral chest) x-ray of chest.The report was compared with the report of 08/12/2014.The image study revealed that there was no pneumothorax.Impression: minimal left mid lung and left basilar atelectasis, as well as a small left pleural effusion.On (b)(6) 2014: the patient was discharged to home.Final diagnoses: chronic obstructive pulmonary disease exacerbation.Acute renal insufficiency, resolved.Hyperkalemia, resolved.Uncontrolled type 2 diabetes.Overall feeling of the patient improved, but still with some wheezing.On (b)(6) 2014: the patient presented for a follow upon copd exacerbation.On (b)(6) 2014: the patient presented with fusion surgery in 2006, stimulator placement, low back pain.The patient underwent ct lumbar.Impression: small covered disc on the left at t11-12.Multilevel generalized disc bulges and facet hypertrophy.Mild canal stenosis at l3-4 with mild to moderate bilateral foraminal stenosis.Post-operative changes at l4-5 with solid posterior lateral fusion on the right and partial posterior lateral fusion on the left.First degree spondylolisthesis at l5-s1 with bilateral pars breaks, postoperative changes with loosening of the s1 pedicle screws bilaterally, mild posterior displacement of intervertebral body bone graft with the pseudoarthrosis of the graft, bilateral partial posterior lateral partial fusions, a large posterior lateral end plate spur on the right and bilateral foraminal stenosis, severe on the right and mild to moderate on the left.Fairly marked denervation atrophy of the posterior paraspinal muscles at l5-s1 bilaterally.Neurostimulator in place.On (b)(6) 2014: the patient presented for a follow up on type 2 diabetes, hyperlipidemia, hypertension and copd.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on (b)(6) 1992: the patient underwent pa and lateral chest x-ray.Impression: negative chest.On (b)(6) 1994: the patient underwent pa and lateral chest x-ray.Impression: linear atelectasis versus interstitial scar at the left lo wer lung field.On (b)(6) 1994: patient was diagnosed with degenerative disc disease, grade 1 spondylolisthesis.On (b)(6) 1999: the patient presented for a follow up on hypertension, copd, history of psvt.Assesment: hypertension, type2 diabetes, chronic back pain.On (b)(6) 2003: patient presented for follow up.Patient presented with hypertension, hyperglycemia.Impression: chest pain.On (b)(6) 2004: patient was admitted.Impression: l5 spondylolisthesis with grade 1 l5-s1 spondylolisthesis.Degenerative instability at l4-5 and l5-s1 with stenosis.On (b)(6) 2006: patient presented for an office visit.Patient presented with hypertension, type 2 diabetes, copd, ed on viagra.On (b)(6) 2011: the patient presented for a follow up.Patient was diagnosed with diabetes mellitus, obesity, esophageal reflux, benign hypertension, hyperlipidemia, coronary atherosclerosis.On (b)(6) 2011: the patient presented for an office visit.Patient was diagnosed with diabetes mellitus, obesity, esophageal reflux, benign hypertension, hyperlipidemia, coronary atherosclerosis.
 
Event Description
It was reported that on, (b)(6) 2009: the patient presented for a follow up on cough and congestion.On (b)(6) 2012: patient presented for follow-up on type ll diabetes.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on: (b)(6) 2004: the patient presented with chief complaint of pain and burning in feet, low back pain, r-leg pain.Patient underwent mri of the lumbar spine.Impression: 1.Grade 1 spondylolisthesis l5 on s1.2.Degenerative disc disease l3/4, l4/5 and l5/s1.Abnormal central disc protrusion extends into the neural foramina bilaterally, slightly greater on the right than the left, at l4/5.3.Central bulging annulus l3/4.4.Minimal central and leftward bulging annulus at t11/12.(b)(6) 2004: the patient was discharged.(b)(6) 2005: patient diagnosed with chest pain, shortness of breath, hypertension, dyslipidemia, tobacco abuse, palpitations.(b)(6) 2002 the patient underwent xrays of the right foot.Impressions: small plantar calcaneal spur.(b)(6) 2002, (b)(6) 2003, the patient was presented for office visit.Assessments: 1) neck pain, 2) lower back pain, 3) le radiculopathy, 4) cervical disc disease, 5) mri evidence of lumbar disc disease with herniation at all levels.6) electrodiagnostic evidence of left l5-s1 radiculopathy as well as right s1 radiculopathy.(b)(6) 2003, (b)(6) 2004 the patient was presented for office visit with low back pain, bilateral sacroilitis, lumbar disc disease, electrodiagnostic evidence of bilateral s1 radiculopathy.Impressions: 1) lower back pain, 2) bilateral le radiculopathy and paresthesia, 3) bilateral sacroilitis, 4) mri evidence of degenerative disc disease at l4-5, l5-s1 levels with disc herniation at l5-s1 encroaching the thecal sac and neural foramina bilaterally.5) electrodiagnostic device evidence of bilateral s1 radiculopathy.(b)(6) 2005 the patient underwent caudal epidural steroid injection with epidurogram under fluoroscopic guidance.Preoperative diagnosis: 1) refractory low back pain, 2) status post back surgery, 3) postlaminectomy syndrome with scarring, 4) lower extremity radiculitis, 5) refractory pains to conservative treatment.(b)(6) 2004, (b)(6) 2005, (b)(6) 2006 the patient was presented for office visit with periods of aggravation of pain.Impressions: 1) low back pain, 2) obesity, 3) lower extremity radiculitis, 4) status post back surgery, 5) post laminectomy syndrome with scarring.6) diabetes mellitus.7) sacroiliac dysfunction.(b)(6) 2006 the patient underwent caudal epidural steroid injection.Impressions: 1) refractory low back pain, 2) status post back surgery.3) post laminectomy syndrome with scarring, 4) lower extremity radiculitis, 5) refractory pains to conservative treatments.(b)(6) 2006, (b)(6) 2007 the patient was presented for office visit with periods of aggravation of pain.Impressions: 1) low back pain, 2) obesity, 3) lower extremity radiculitis, 4) status post back surgery, 5) post laminectomy syndrome with scarring.(b)(6) 2007 the patient was presented for office visit.Impressions: 1) low back pain, 2) lower extremity radiculitis, 3) status post back surgery, 4) post laminectomy syndrome with scarring, 5) persistent pain, 6) radiculitis.(b)(6) 2007 the patient underwent spinal cord stimulation trial for lower extremity neuropathic pain.Preoperative diagnosis: 1) refractory low back pain, 2) status post back surgery, 3) postlaminectomy syndrome with scarring, 4) lower extremity radiculitis, 5) neuropathic pain, 6) refracted conservative treatment.(b)(6) 2007 the patient was presented for office visit.Impressions: low back pain, lower extremity radiculitis with paresthesia, status post laminectomy syndrome with scarring, neuropathy, worsening of the pain.(b)(6) 2008 the patient was presented for office visit with low back pain, lower extremity radiculitis, status-post back surgery and postlaminectomy syndrome with scarring and radiculitis.
 
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Brand Name
INFUSE BONE GRAFT
Type of Device
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer (Section G)
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis TN 38132
Manufacturer Contact
huzefa mamoola
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key4348846
MDR Text Key5137920
Report Number1030489-2014-04804
Device Sequence Number1
Product Code NEK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,consumer
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 11/09/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Health Professional
Device Catalogue Number7510800
Device Lot NumberM112001ABD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/08/2014
Initial Date FDA Received12/20/2014
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received09/15/2015
10/28/2015
12/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Weight109
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