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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 Bronchitis (1752); Chest Pain (1776); Dyspnea (1816); Pulmonary Emphysema (1832); Headache (1880); Pyrosis/Heartburn (1883); Hematoma (1884); High Blood Pressure/ Hypertension (1908); Nausea (1970); Neuropathy (1983); Pain (1994); Renal Failure (2041); Skin Irritation (2076); Urinary Tract Infection (2120); Vomiting (2144); Stenosis (2263); Numbness (2415)
Event Type  Injury  
Event Description
It was reported that the patient underwent a tlif and posterolateral fusion at l4-5 -2/acs with an interbody cage and rhbmp-2/acs.Following surgery, the patient followed up with her physician.She began to develop radiating pain to her legs.The patient has never recovered from her surgery, and continues to experience daily, disabling pain that prevents her 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
Per medical records, it was reported that on, (b)(6) 2014 patient underwent ct scan of lumbar spine.Impression: anterior and posterior fusion of l4 and l5.2.Mild scoliosis and grade 1 anteriolisthesis at l4-5.3.Mild spinal stenosis at l2-3 and l3-4.4.Bilateral neutral foramen narrowing at l2-3 and l3-4, which may affect the exiting nerve roots.Less severe neural foramen narrowing is seen at l5-s1.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On an unknown date in 2008, the patient was diagnosed for back pain.On an unknown date in 2014, the patient underwent an unknown radiology examination.Post-surgery, the patient continues to experience increased back and leg pain.She also experiences hip pain that was not present before the surgery.Since the surgery, the patient continues to follow-up with back pain.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that on, (b)(6) 1999: the patient presented for a follow up appointment after discharge.She has been anxious and was not able to sleep.On (b)(6) 1999: the patient presented for follow-up of psychiatric disorder.Diagnosis: general anxiety and dysthymia.On (b)(6) 1999: the patient presented for a follow up appointment.On (b)(6) 2001, (b)(6) 2002: the patient presented for a regular followup for back pain.Assessment: back pain and benign hypertension.On (b)(6) 2001: the patient underwent x rays of the thoracic spine due to persistent back pain.Impression: alignment is anatomic.No compression fracture is identified.There is mild to moderate multi-level endplate degenerative change particularly evident near the thoracolumbar junction.The patient underwent x rays of the lumbosacral spine due to persistent back pain.Impression: alignment is anatomic.No compression fracture is identified.There is mild to moderate multi-level endplate degenerative change.The disc spaces are preserved.There is posterior degenerative change at l4-l5 and l5-s1.On (b)(6) 2002: the patient presented for psychotherapy.Assessment: chronic pain, chronic back problem, degenerative disc disease.On (b)(6) 2002: the patient underwent bilateral mammogram.Impression: no evidence of malignancy.On (b)(6) 2003: the patient presented for refill for medicines.Assessment: otitis externa, possibly media; hypertension; hyperlipidemia.On (b)(6) 2003: the patient presented with lots of pain in her right back and hip.She also had some pain in her ears and congestion.Assessment: chronic back and hip pain.The patient was also given psychotherapy.On (b)(6) 2003: the patient underwent x-rays of the lumbosacral spine due to severe back pain.Impression: there is no bone deformity.No disc space abnormality.Mild spondylosis of l3 and l4 and probably l5.The patient underwent x rays of the hip due to chronic hip pain.Impression: no bone deformity or joint abnormality.The patient also underwent psychotherapy.Assessment: generalized anxiety disorder; chronic open; orthopedic problems.On (b)(6) 2004: the patient presented with right hip pain radiating down the back of the thigh on flexion of hip, shooting down pain.The patient also had chronic low back pain.On (b)(6) 2004: the patient presented with acute severe low back and right hip pain.The patient underwent x-rays of the lumbosacral spine due to backache.Impression: diffuse spondylosis of lower thoracic and lumbar vertebrae with osteoarthritis changes of facet joint at l4-5 and l5-s1.On (b)(6) 2004: the patient underwent mri of the lumbar spine without and with contrast due to exacerbation of low backache with right lumbar radiculopathy.Impression: degenerative facet arthropathy at l4-l5 and l5-s1.Degenerative spondylolisthesis at l4-l5 and diffuse disc bulge create central and lateral recess stenosis.There is also degenerative disc change at t12-l1.The patient was discharged home.On (b)(6) 2004: the patient consulted for hyperlipidemia and chronic back pain.On (b)(6) 2004: the patient presented for psychotherapy.Assessment: schizoaffective disorder (b)(6) 2004: the patient presented with tremendous pain in right hip and back.The pain was radiating in nature.On (b)(6) 2004: the patient presented for psychotherapy.Assessment: schizoaffective disorder, chronic back pain and orthopedic problems.On (b)(6) 2005: the patient presented for cognitive psychotherapy.Assessment: schizoaffective disorder.On (b)(6) 2005: the patient presented due to chief complaint of right sided upper back pain.On (b)(6) 2005: the patient presented for an office visit due to aching back.On (b)(6) 2006: the patient presented with chief complaint of back pain.On (b)(6) 2007: the patient presented with chief complaint of left shoulder, left hip pain and also sore throat and ears.On (b)(6) 2007: the patient presented with complaint of pain in left hip.On (b)(6) 2007: patient underwent x-rays of hip due to fall and pain.Impression: no acute fracture or dislocation; first metatarso -phalangeal joint osteoarthritis.On (b)(6) 2007: patient presented with chief complaint of hip pain and ambulation difficulties.On (b)(6) 2007, (b)(6) 2008: patient presented with the chief complaint of back pain, sore throat and left ear pain.On (b)(6) 2007: patient presented for discussing pain medication.On (b)(6) 2008: the patient presented for revaluation in preparation for a lumbar epidural steroid injection.She continued to have pain in the lower back radiating down her lower extremities especially down her left to her hip as far as her ankle usually.Patient's pain was aggravated by all activities.On (b)(6) 2008: patient presented with the chief complaint of ear pain, cold, headache and hip pain.On (b)(6) 2008: the patient presented for evaluation of bilateral, lower, back pain.Physical examination revealed left leg weakness.The patient also underwent mri of the lumbar spine without contrast due to back pain.Impression: no comparison.Multilevel degenerative disc change most significant at the l4-5 level where a combination of ligamentous and facet hypertrophic changes and disc bulge causes mild to moderate spinal canal stenosis.There is no significant foraminal encroachment at this level; small synovial cyst from the left facet joint of l4-5 level.The patient also underwent x rays of the chest due to back pain.Impression: no acute intrathoracic process; atherosclerotic vascular disease; mild degenerative disk disease with scoliosis.Pelvic radiographs were also taken on account of patient's hip pain.Impression: no acute fracture or dislocation; degenerative changes involving the hips bilaterally, sacroiliac joints bilaterally, visualized lower lumbar spine, and pubic symphysis.On (b)(6) 2008: the patient underwent nuclear bone imaging.Impression: no abnormal increased uptake of the hips; mild degenerative change at l3; stress change at patella and "first toss" bilaterally.On (b)(6) 2009, (b)(6) 2010: the patient presented for following reasons: nausea, otalgia, shortness of breath and cough.Physical exam revealed some kyphosis in thoracic area and throat mild erythema.On (b)(6) 2009, (b)(6) 2010: the patient presented for medication refill.The patient also had left hip pain and pain radiated to left heel.The patient was also diagnosed with chronic low back pain, anxiety, hypertension and sciatica.On (b)(6) 2010: the patient presented with the chief complaint of "uri" symptoms.Impression: bronchitis (b)(6) 2010, (b)(6) 2011: patient presented with chest pain, headache, lumbago, joint pain, skin sensation disturb, numbness in left arm and left jaw.
 
Manufacturer Narrative
 
Event Description
It was reported that on, (b)(6) 2003 the patient presented for an office visit.(b)(6) 2004 the patient presented for an office visit.On (b)(6) 2004: the patient presented to the office with complaints of dental disorder (toothache) and hypertension.On (b)(6) 2005: the patient presented for an office visit with complaints of dental disorder and unspecified dental caries.On (b)(6) 2006: the patient presented for an office visit with complaints of back upper dorsal, lumbosacral pain, cervical and hip pain.The patient underwent radiological tests of the spine and hips.Impression cervical spine: degenerative changes of the cervical spine.No acute osseous abnormality is identified.Impression lumbar spine: degenerative changes of lumbar without acute osseous abnormality.On (b)(6) 2006: the patient presented to the office with complaint of pneumonia.Ecg showed normal sinus rhythm.The patient underwent x-ray of the chest.Impression: no acute cardiopulmonary abnormality.On (b)(6) 2006: the patient presented to the office with complaints of back pain and chest tightness and possible pulmonary embolism and was diagnosed with the following: cervical spondylosis, lumbosacral spondylosis, hypopotassemia, chest pain, hypertension, family history of ischemic heart disease.The patient underwent chest ct with contrast.Impression: no acute cardiopulmonary abnormality.Nonspecific mediastinal adenopathy, none pathologically enlarged.Bibasilar atelectasis.A comparison of the back x-ray was done.Impression: degenerative disk disease, stable in appearance.On (b)(6) 2006 the patient underwent cardiolite exam.Impression: no evidence of stress induced ischemia.On (b)(6) 2006: patient presented with abdominal pain, pneumonia, abnormal electrocardiogram, diaphragmatic hernia.On (b)(6) 2006: the patient presented for an office visit.The patient underwent a radiological exam of the left hip.There is mild to moderate osteoarthritic change.There is no fracture subluxation or other acute bony abnormality.The pelvis appears to be intact.On (b)(6) 2006: the patient presented for an office visit.The patient underwent mri of the lumbar spine.A comparative study was done.L1-l2: there is some minimal disk desiccation at this level.This level is otherwise unremarkable.L2-l3: there is some minimal disk desiccation.This level is otherwise unremarkable.L3-l4: there is mild disk desiccation at this level.There is some minimal facet joint hypertrophy, diffuse disk bulge and spurring with minimal central canal narrowing.The neural foramina remain patent.L4-l5: spurring, facet joint hypertrophy and diffuse disk bulge contributes to moderate central canal narrowing.The neural foramina remain patent.L5-s1: there is mild disk desiccation at this level.No focal disk herniation or significant stenosis is identification.On (b)(6) 2008: the patient was diagnosed with backache, sciatica, chronic pain syndrome, hypertension and tobacco use disorder.The patient stated that her mobility was limited due to pain.On (b)(6) 2012: the patient presented with complaints of midsternal chest tightness.The patient underwent a ct exam with contrast which was negative except for some atherosclerosis of the aorta.Assessment: chest pain , suspicious of unstable angina.Accelerated hypertension; active smoker; chronic back pain; dvt prophylaxis.On (b)(6) 2012: the patient underwent a myocardial exam.Impression: pharmacologic stress ecg is negative for ischemia at level of heart rate achieved.Patient had no chest pain or arrhythmias during stress.The left ventricle does not appear dilated.Normal wall motion in stress.Gated ef = 70%.Nuclear perfusion is negative for ischemia or prior infarction.On (b)(6) 2013: the patient underwent left hip x-ray.Impression: mild degenerative changes in the left hip and left si joint.No evidence of acute fracture, dislocation or destructive lesions.On (b)(6) 2013: the patient presented with chest pain and hypertension and was diagnosed with anxiety , hypertension and tobacco use.On (b)(6) 2013: the patient presented for an office visit.On (b)(6) 2013: the patient presented with complaint of low back pain and underwent x-ray of the lumbar spine.Impression: anatomic alignment status post posterior fusion at l4-l5.No acute abnormalities are identified.Multilevel degenerative disc disease is evident.
 
Manufacturer Narrative
(b)(6).(b)(4).
 
Event Description
Per medical records, it was reported that on (b)(6) 2001: patient presented with chest pain, nausea, shaking.On (b)(6) 2002: patient presented with pain/numbness right hip and leg.On (b)(6) 2002: patient presented with back pains.On (b)(6) 2002, (b)(6) 2011: patient presented with the following diagnosis: abdominal pain epigastric, hematuria, hypertension, esophageal reflux, chest pain.On (b)(6) 2002: patient presented with chest abdominal neck pain.On (b)(6) 2002: patient presented with low back pain, right hip pain.On (b)(6) 2002: patient presented with neck pain.On (b)(6) 2003: patient presented with ear infection pain in chest.On (b)(6) 2003: patient presented with pain in the left arm.On (b)(6) 2003: patient presented with the following diagnosis: joint pain pelvis, tobacco use disorder, hypertension, esophageal reflux, chest pain.On (b)(6) 2003: patient presented with high bp, rib pain, sick at stomach.On (b)(6) 2003: patient presented with chest pain.On (b)(6) 2003, (b)(6) 2004: patient presented with hip pain.On (b)(6) 2004: patient presented with pain and tingling right leg.On (b)(6) 2004: patient presented with chest pressure high blood pressure.On (b)(6) 2004: patient presented with left hip back pain and vomiting.On (b)(6) 2004: patient presented with leg and hip pain.On (b)(6) 2005: patient presented with chest pain, abdominal pain, precordial pain.On (b)(6) 2005: patient presented with backache, pain in thoracic spine, pain upper back between shoulder.On (b)(6) 2005: patient presented with chest pain, urine tract infection, diaphragmatic hernia, abnorm electrocardiagram.On (b)(6) 2005: patient presented with precordial pain, tietze's pain, hematuria, esophageal reflux, chest pain.On (b)(6) 2005: patient presented with chest pain, nausea.On (b)(6) 2005: patient presented with cellulitis of neck.On (b)(6) 2005, (b)(6) 2006: patient presented with dental disorder, dental caries.On (b)(6) 2006: patient presented with abdominal pain, pneumonia, abnorm electrocardiogram, diaphragmatic hernia.On (b)(6) 2006: patient presented with chest pain, joint pain shoulder, and painful respiration.On (b)(6) 2007: patient presented with chest pain, acute bronchitis.On (b)(6) 2007: patient presented with pain in limb, fx phalanx, foot closed.Patient underwent x-ray of the foot.On (b)(6) 2007: patient presented with contusion of hip, joint pain pelvis, injury left hip.On (b)(6) 2007: patient presented with lumbago, sciatica, left hip pain, numb.On (b)(6) 2007: patient presented with severe low back pain.On (b)(6) 2007: patient presented with spinal stenosis- lumbar.On (b)(6) 2007: patient presented with back and leg pain.On (b)(6) 2007: patient presented with spinal stenosis- lumbar, disc degeneration.On (b)(6) 2007: patient presented with joint pain pelvis, sciatica, left hip pain.On (b)(6) 2007: patient presented with disc degeneration.On (b)(6) 2007, (b)(6) 2008: patient presented with spinal stenosis- lumbar, back pain.On (b)(6) 2007: patient presented for follow-up.Patient presented with degenerative disc disease.On (b)(6) 2008: patient presented with spinal stenosis- lumbar, arthropathy.On (b)(6) 2008: patient presented with chronic hip pain.On (b)(6) 2008: the patient underwent the procedure: lumbar epidural steroid injection.On (b)(6) 2008: patient presented with joint pain- pelvis.On (b)(6) 2008: patient presented with ems/hip pain out of pain meds, back pain, spondylolisthesis.On (b)(6) 2008: patient presented with lumbosacral neuritis, spinal stenosis-lumbar.On (b)(6) 2008: patient presented with joint pain pelvis, spondylolisthesis.On (b)(6) 2008, (b)(6) 2007: patient presented with lumbosacral neuritis, spinal stenosis-lumbar, lumbago, left hip pain.On (b)(6) 2008: patient presented with lumbago, chronic pain, lumbosacral spondylosis, epidural hematoma.On (b)(6) 2008: patient presented with chest pain, joint pain, chronic pain, pain in limb.On (b)(6) 2008: patient presented with backache, lumbago, anxiety, neuralgia/ neuritis.On (b)(6) 2008: patient presented with spinal stenosis- lumbar.On (b)(6) 2008: patient presented with joint pain pelvis, backache.On (b)(6) 2008: patient presented with chest pain, sciatica.On (b)(6) 2008: the patient presented with left leg pain.The patient underwent 4 view of lumbar spine.Impression: unstable anterolisthesis of l4 relative to l5 which is more pronounced in flexion than on the neutral and extension views.Changes of spondylosis are present throughout the lumbar spine.On (b)(6) 2008: the patient underwent 3 views of panorex and oblique ap views.Impression: thin rim of radiolucency surrounding the roots of the macilal two remaining left mandibular teeth.The possibility of developing odontogenic abscess cannot be excluded.This may be further evaluated via ct scan of the facial bones including mandible with contrast.Patient is nearly edentulous.On (b)(6) 2008: the patient underwent x-ray of lumbar spine.Impression: intraoperative views demonstrating fusion hardware at l4-5.The patient presented with following pre-op diagnosis.Left l4-5 radiculopathy from lumbar instability and a left sided synovial cyst.Procedure: decompressive laminectomy facetectomy at l4-5.Posterolateral arthrodesis l4-5.Nonsefmental pedicle screw instrumentation at l4-5 with pedicle screw system.Harvest local bone through same incision.Use of bmp morselized allograft for posterolateral and interbody fusion.Transforaminal lumbar interbody fusion with preparation of interspace, l4-5.Placement of intervertebral biomechanical device 12 x 22 mm peek spacer.Posterolateral listhesis, l4-5.Perop: the bone was morselized and saved for later use in the posterolateral interbody fusion.A high speed 6 mm diamond bur was then used to perform a laminectomy starting caudally aat l5, working my way rostrally to l4.The pedicles were widely palpable at l4-l5.K-wires which were in good position on x-ray was tapped with a 5.5 ml cannulated tap placing 6.5 x 50 mm screws at l4 and l5 with good purchase.Then bone full with local bone and bmp soaked sponges anterior and medially to the interbody spacer.A 12 x 22 mm peek intervertebral biomechanical device was then placed obliquely across the disk space and it was recessed appropriately from the posterior vertebral body edge.Two 4 cm rods were used.The patient underwent a transforaminal lumbar interbody fusion at l4-5 using a fusion cage, as well as a posterolateral fusion with rhbmp-2/acs at the same level.Following surgery, the patient followed up with her physician.She began to develop radiating pain to her legs.The patient has never recovered from her surgery, and continues to experience daily, disabling pain that prevents her from performing many basic activities of daily living.On (b)(6) 2008: the patient discharged home with following diagnosis: left l4 and l5 radiculopathy with lumbar instability and a left sided synovial cyst.On (b)(6) 2008: the patient went for an office visit.On (b)(6) 2008: patient presented with chest pain, joint pain pelvis, lumbosacral neuritis, right hip pain.On (b)(6) 2008: patient presented with chest pain.On (b)(6) 2009: patient presented with lumbosacral neuritis.The patient underwent x-ray of lumbar spine.Impression: orthopedic rods at l4 and l5 without evidence of loosening or infection.Multilevel mild spondylosis.On (b)(6) 2009: the patient went for an office visit.On (b)(6) 2009: the patient presented with pain in her lower thoracic region and her left hip.On (b)(6) 2009: patient presented with acute bronchitis, cough, hypertension.On (b)(6) 2009: the patient underwent mri of lumbar spine without contrast.Impression: multilevel degenerative changes.On (b)(6) 2010, on (b)(6) 2009: patient presented with the following diagnosis: backache, urin tract infection, esophageal reflux, anxiety state, hypertension, chest pain.On (b)(6) 2010: patient presented with the following diagnosis: backache, depressive disorder, chest pain, hypertension.On (b)(6) 2010: patient presented with painful respiration, acute bronchitis.On (b)(6) 2010: patient presented with acute renal failure, backache, hypertension, dysthymtic disorder.On (b)(6) 2010, (b)(6) 2011: patient presented with chest pain, headache, lumbago, joint pain, skin sensation disturb.On (b)(6) 2011: patient presented with chest pain, jaw pain, dental disorder.On (b)(6) 2011: patient presented with backache, sprain lumbar region.On (b)(6) 2011, on (b)(6) 2008: patient presented with abdominal pain, painful respiration, sprain of ribs, backache, chronic pain.On (b)(6) 2012: patient presented with postlaminect synd-lumbar, lumbosac disc design.Impression: failed back surgery syndrome, lumbar degenerative disc disease, lumbar facet arthropathy.On (b)(6) 2013: the patient presented with chests pain nausea and vomiting.On (b)(6) 2013: patient presented with right hip and back pain.On (b)(6) 2014: the patient presented with esophagitis or heartburn.On an unknown date in 2014, the patient underwent an unknown radiology examination.Post-surgery, the patient continues to experience increased back and leg pain.She also experiences hip pain that was not present before the surgery.Since the surgery, the patient continues to follow-up with back pain.On (b)(6) 2015, the patient presented with hypertension, anxiety, arthritis and back pain.Gerd went for an office visit for follow up.On (b)(6) 2015: patient presented with chronic back pain, chronic bronchitis and emphysema.
 
Manufacturer Narrative
Additional information: evaluation codes.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.
 
Event Description
It was reported that on (b)(6) 2001, the patient presented with rule out gallbladder and underwent us abdominal scan.Impression: mild thickening of the gallbladder wall.Could be due to inflammatory process.Can not confidently evaluate the pancreas due to overlying bowel gas.On (b)(6) 2002: patient presented with pain/numbness right hip and leg and underwent spine x ray.Impression: mild degenerative changes and mild scoliosis.On (b)(6) 2002, the patient presented for chest x ray.Impression: no acute infiltrates.On (b)(6) 2002, the patient presented with abdominal pain and underwent ct abdomen.On (b)(6) 2002, the patient presented with renal calculi/ hydronephrosis and underwent ct abdomen.Impression: no obstructive uropathy or urolithiasis identified.On (b)(6) 2002, the patient presented for complete knee x ray.No fracture or dislocation.Tiny spur at the intercondyloid of the tibia.Also, tiny spur at the posterior aspect of the patella.On (b)(6) 2002: patient presented with low back pain, right hip pain.The patient underwent lumbar spine x rays.On (b)(6) 2002, the patient presented with abdomen pain.On (b)(6) 2003, the patient presented with pain and underwent chest x ray.Impression: hyperinflation of lungs compatible with copd.On (b)(6) 2003: patient presented with chest pain.The patient underwent ct scan of the abdomen and pelvis.Findings: there is no calculus in either renal collecting system or ureter.There is no hydronephrosis.The patient also had chest x rays.Impression: normal chest.No change since (b)(6) 2003.On (b)(6) 2004: patient presented with left hip back pain and vomiting.The patient underwent complete hip x -rays.Result: lumbar spine: moderate scattered degenerative changes with spur formation which also involves the visualized lower dorsal.No acute bony abnormality.Very minimal left convexed scoliosis.Opaque clips in the right upper quadrant.Left hip: minimal degenerative changes in the left hip.No acute bony abnormality.No joint space narrowing or any abnormal calcification.Opaque clips in the pelvic area noted.Moderate degenerative changes in the pubic bones.On (b)(6) 2005, the patient presented with pain and underwent xray of ribs unilateral.Dorsal spine: no acute bony abnormality.Minimal to moderate scattered degenerative changes with spur formation noted.No malalignment.Opaque clips in the right upper quadrant.Left ribs: minimal deformity of the left 1oth anterior rib which could either be from old or acute cortical fracture.Suggest clinical correlation.There is no accompanying pa chest taken.The patient also had ct abdomen.Impression: no opaque calculus in the kidneys, ureters and bladder.On (b)(6) 2005: patient presented with precordial pain, tietze's pain, hematuria, esophageal reflux, chest pain.The patient had x ray abdomen.Impression: gas pattern is nonspecific.Follow up plain films may be mm/ib of further benefit if clinically indicated.Moderate/large amount of feces in the colon.Postop clips associated with the abdomen and pelvis.Degenerative changes of the spine.Mild s-shaped curvature of the thoracic and lumbar spine.Tiny granuloma left lung.On (b)(6) 2006, the patient presented with complaint of abdomen pain, underwent x ray of abdomen.Impression: possible fecal impaction.On (b)(6) 2007: patient presented with chest pain, acute bronchitis.The patient presented for abdomen x ray.Impression: mild reflex ileus.Impression for pa chest: mild cardiomegaly.Arteriosclerosis.Mild chronic obstructive pulmonary disease/bronchitis.No acute process.On (b)(6) 2007: patient presented with pain in limb, fx phalanx, foot closed.Patient underwent x-ray of the foot.Impression: minimally displaced fracture base of the proximal phalanx of the fourth toe.On (b)(6) 2007, the patient presented for mri of lumbar spine.Conclusion: marked central stenosis l4-5.Moderate spondylosis, multiple levels.On (b)(6) 2008: patient presented with ems/hip pain out of pain meds, back pain, spondylolisthesis.The patient underwent x ray of lumbar spine.Impression: impression: diffuse degenerative changes with mild convexity of upper to mid lumbar spine to the left.No fracture seen, however, there is grade i anterolisthesis of l4 anterior to l5.On (b)(6) 2008, the patient presented for chest x ray.On (b)(6) 2008: patient presented with lumbago, chronic pain, lumbosacral spondylosis, epidural hematoma.The patient underwent mri of lumbar spine.Impression: multilevel degenerative changes (b)(6) 2008: patient presented with chest pain, joint pain, chronic pain, pain in limb.The patient underwent chest x ray.Impression: there is no radiographic evidence of acute cardiopulmonary disease.On (b)(6) 2009, the patient underwent chest x ray due to possible pneumonia.Impression: right lower lobe infiltrate.On (b)(6) 2009, the patient presented for ct abdomen/ pelvis.Impression: mild dilatation of short segment of proximal jejunum that is nonspecific.The patient also had chest x ray.Impression: no acute infiltrate or effusion.On (b)(6) 2009, the patient presented for chest x rays.Impression: normal chest radiograph.On (b)(6) 2010: patient presented with painful respiration, acute bronchitis.The patient had a history of cough and presented for cta chest.Impression: no acute process or pulmonary embolus.On (b)(6) 2010: the patient presented with the chief complaint of "uri" symptoms.Impression: bronchitis.The patient also had chest x ray.Impression: normal chest radiograph.On (b)(6) 2010: patient presented with acute renal failure, backache, hypertension, dysthymic disorder.The patient had shortness of breath and abdomen pain.The patient presented for ct abdomen <(>&<)> pelvis.Impression: 1 bilateral paranephric stranding suggests perhaps recently passed renal stone.The patient also underwent chest x ray.Impression: cannot exclude right lower lobe infiltrate.On (b)(6) 2010, the patient presented for ct scan of head.Impression: age related involutional changes.Focal extra axial csf space widening overlying the left parietal lobe; left mastoid inflammatory change.On (b)(6) 2011: patient presented with chest pain, headache, lumbago, joint pain, skin sensation disturb, numbness in left arm and left jaw.The patient underwent lumbar spine x ray.Impression: no acute abnormality.Multilevel spondylosis.Laminectomy at l4 <(>&<)> l5 with orthopaedic hardware in position without evidence of loosening or infection.05 <(>&<)>.On (b)(6) 2011, the patient underwent chest x ray.Impression: normal chest.On (b)(6) 2011, the patient presented for complete hip x-ray and chest x ray.Impression: no acute abnormality.On (b)(6) 2011, the patient presented for lumbar xrays.Impression: s/p lower lumbar spinal fusion.Narrowing of the disc space between l2-3 and to a lesser degree, (b)(6) 2013, the patient had chest x ray.Impression: no acute pulmonary disease.On (b)(6) 2013, the patient presented with pain <(>&<)> hip pain.The patient had complete hip x ray.Impression; unremarkable right hip.On (b)(6) 2013: patient presented with right hip and back pain.The patient underwent x ray of lumbar spine.Impression: disc spacer between l4-5 with minimal anterolisthesis of l4 with respect to l5.Orthopedic hardware is intact.Multilevel spondylosis of lumbar spine.On (b)(6) 2014, the patient presented with back pain and had x ray of lumbar spine.Impression : intact orthopedic hardware at l4-5.Degenerative changes in distribution.Between l3-4.On (b)(6) 2015: patient presented with chronic back pain, chronic bronchitis and emphysema.The patient underwent chest xray.Impression: no acute pulmonary disease.On (b)(6) 2015, the patient underwent chest ct scan.Impression: no evidence of pulmonary embolism.On (b)(6) 2015, the patient underwent chest x rays.Impression: no acute disease.On (b)(6) 2015 , the patient presented with pain and underwent x ray of hip.Impression: no acute findings in the left hip.
 
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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 Key4393518
MDR Text Key17933086
Report Number1030489-2015-00047
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,Followup
Report Date 04/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/01/2010
Device Catalogue Number7510800
Device Lot NumberM110710AAB
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/20/2015
Initial Date FDA Received01/07/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Not provided
Supplement Dates FDA Received07/29/2015
01/01/2016
02/02/2016
05/09/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/23/2008
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 Outcome(s) Other;
Patient Age00064 YR
Patient Weight77
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