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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 Diarrhea (1811); Dyspnea (1816); Headache (1880); High Blood Pressure/ Hypertension (1908); Pain (1994); Tingling (2171); Dizziness (2194); Numbness (2415); Respiratory Tract Infection (2420); Sweating (2444); Palpitations (2467); Sleep Dysfunction (2517)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Neither device nor applicable imaging studies returned to manufacturer for evaluation.
 
Event Description
It was reported that on (b)(6) 2005: the patient underwent mri of spinal cord without contrast.Impressions: minor concentric disc bulging at multiple levels.No evidence of disc herniation or central canal stenosis.On (b)(6) 2006: the patient presented with low back pain on (b)(6) 2006: the patient underwent mri of lumbar spine with and without contrast.Impression: stable, minor concentric disc bulging at multiple levels and some mild facet arthropathy.No focal disc herniation.On (b)(6) 2006: patient presented with numbness, tingling and pain.After mri the impression: possible l5 radiculopathy.On (b)(6) 2006: the presented with radiculopathy and femoral cutaneous nerve compression.On (b)(6) 2006: the patient presented with left leg pain with foraminal stenosis.On (b)(6) 2006: the patient presented with back and leg pain.On (b)(6) 2006, (b)(6) 2007, (b)(6) 2008: the patient presented for follow-up with complaint of numbness and back pain.On (b)(6) 2007: the patient presented with preoperative diagnosis of left l5 neural foraminal stenosis and l5 radiculopathy and underwent l5 foraminotomy procedure.On (b)(6) 2007: the patient was discharged.On (b)(6) 2009: the patient presented with low back pain and spasms in the posterolateral aspect of the leg and calf.On (b)(6) 2009: the patient underwent mri of lumbar spine with and without contrast.Impression: degenerative and postoperative changes in the lower lumbar spine, no disc herniation or spinal canal stenosis is evident.On (b)(6) 2009: the patient presented for follow-up.Impressions: acute and chronic lower back pain.On (b)(6) 2009: the patient presented with numbness and back pain.Patient underwent physical examination.Impression: persisting discogenic lower back pain.On (b)(6) 2010: the patient underwent radiology examination of lumbar spine with and without contrast.Findings: postoperative changes on the left at l5-s1 without evidence of focal disc protrusion, extrusion or spinal stenosis.Impression: mild degenerative change patient underwent mri l-spine with and without contrast.Impressions: postoperative changes on the left at l5-s1 without evidence of focal disc protrusion, extrusion or spinal stenosis.On (b)(6) 2010: the patient presented for follow-up, wherein patient has had a new mri showing degenerative changes of the l3-4 disc, more significant degenerative changes at l4-5 and more disc collapse at ls-s1 with discogenic change of the endplates.He has failure of several years of conservative treatment for his discogenic lower back pain.He feels he can no longer tolerate the symptoms.On (b)(6) 2010: the patient presented with chief complaint of low back pain.Patient underwent x-ray.Impression: discogenic low back pain with failure of conservative treatment going on a number of years.He feels he can no longer tolerate the pain and is fairly desperate to have something done.Patient underwent intraoperative multimodality neuro monitoring.Impressions: this multimodality intraoperative monitoring study showed no changes in the parameters monitored that would suggest intraoperative neural injury occurring.Patient underwent xr l-spine 2-3 views.Impression: postoperative fusion from l3-s i.On (b)(6) 2010: the patient presented with preoperative diagnosis of degenerative disc disease, discogenic low back pain, and neural foraminal stenosis l5.The patient underwent revision laminectomy l5, transforaminal lumbar interbody fusion l4-l5 and l5-s1 with insertion of intervertebral cages, use of local autograft rh-bmp2/acs and posterior fusion l3-s1 with pedicle screw instrumentation, use of local autograft and rh-bmp2/acs.Per-op notes: the patient was brought to the operating room.Lateral fluoroscopy was used to identify the l3-si level.Pedicle screws were placed bilaterally at the l3, l4, ls, and si level in the following manner.In the lumbar vertebra, the starting hole was found in the mid portion of the transverse process and the base of the facet.A bur was used to initiate a starting hole.The hole was cannulated with a lenke probe, tapped, and the screws were placed.The screws , size 7.5 rnm in diameter.All screws were then stimulated with intraoperative emg.They all stimulated safely.They looked good on ap and lateral fluoroscopy.A revision laminectomy of l5 was performed by carefully dissecting out the previous laminotomy defect at the 14 and l5 level.The spinous processes of l4 and l5 were removed.The lamina of l5 was resected with kerrison rongeurs, carefully dissecting off the scar tissue.The disc was then identified.At each level, the annulus was incised, and the disc was removed with pituitary rongeurs, various curettes, and endplate shavers.The endplates were prepared down to good bleeding bone.At each level, 6 ml of morsellized autograft were impacted into the disc spaces of l4-l5 and l5-si.At the l5-sl level, i used a 10x 30-mm cage.At the 14 level, i believe it was an 11-mm cage.Both cages were inserted under fluoroscopic guidance and had a good interference fit.Once they were into position, the distraction was.Removed.Compression was applied across the l4-l5 and l5-s1 levels bilaterally.Final x-rays showed all the implants to be in good position and of appropriate length.The wound was then irrigated with pulsatile lavage.The blockers were tightened with a torque wrench.The posterior elements from l3-s1 were decorticated with a high-speed burr and abundant autograft, rh-bmp2/acs, as well as some demineralized bone matrix, were packed in the posterolateral gutters bilaterally.Once these were in position, a drain was placed in the wound and brought out through a separate stab incision.The lumbodorsal fascia was closed with #1 vicryl sutures.The subcutaneous tissues were closed with 2-0 vicryls, and the skin was closed with interrupted nylon sutures.On (b)(6) 2010: the patient underwent radiology examination in which frontal, lateral and cone down lumbosacral views were obtained.Impressions: postoperative fusion from l3-s1.Patient still had the complaint of numbness and tingling on (b)(6) 2010: the patient was discharged from hospital with discharge diagnoses: revision laminectomy l5, transforaminal lumbar interbody fusion l4-l5, l5-s1, use of local autograft infuse and posterior fusion l3-s1 with pedicle screw instrumentation.On (b)(6) 2010: the presented for follow-up with complaint of back pain.On (b)(6) 2010: the patient underwent x-rays of lumbar spine.18 may 2010: the patient presented for physical exam.Ros revealed: neuro/psychiatric: dizziness, lightheadedness on (b)(6) 2010: the patient presented with high level of cholesterol.25 may 2010: the patient underwent 24 hour real time holter monitoring.Impression: there are very rare premature supraventricular contractions, the vast majority of which are asymptomatic and not associated with any sustained supraventricular arrhythmia.Two of seven symptomatic spells did include single premature supraventricular contraction.Although most of the very rare supraventricular ectopy is asymptomatic, conceivably some of it may have corresponded to two of his episodes of palpitations.The remaining symptomatic episodes have no correlation for change.Electrocardiogram or rhythm.On (b)(6) 2010: the patient presented for follow-up and complaint of low back pain.On (b)(6) 2010, (b)(6) 2011: the patient presented with low back pain and palpitations.On (b)(6) 2010 : the patient underwent xr chest 2 views pa and lat.Conclusion: no interval change and no acute airspace disease identified.On (b)(6) 2010: ros revealed occasional ringing in ears, palpitations, shortness of breath, diarrhea, back problems, pain and stiffness, depressed nervous and anxious.The patient underwent ekg and diagnosed with premature atrial contractions and bradycardia, on atenolol.On (b)(6) 2010: the patient underwent echocardiograph.Conclusion: difficult study due to difficult acoustic windows.Mild left atrial enlargement.Normal left ventricular size and function.No valvular abnormalities.Normal pulmonary artery pressure.No obvious diastolic dysfunction.The underlying heart rate is around 70 beats per minute.No previous studies for comparison.Impression: sinus rhythm, sinus tachycardia, nonspecific repolarization abnormalities on (b)(6) 2010: the patient was presented with chief complaint of chest pain, palpitation/arrhythmias.Ros revealed: chest pain, palpitation, depression, joint pain, myalgia.Patient underwent physical examination.Impression: pacs, chest pain.On (b)(6) 2007, (b)(6) 2010, (b)(6) 2011: the patient presented for follow-up.On (b)(6) 2011: the patient underwentxr chest 1 view.Impression: limited inspiration without evidence of acute intrathoracic disease.On (b)(6) 2011: the patient presented for second opinion for ongoing palpitation.Ros revealed: dyspnea, weight loss, tinnitus, claudication, edema, chest pain, palpitation, diaphoresis, stress, nervousness, depression, back pain, joint pain, joint stiffness impression: symptomatic premature atrial contractions.On (b)(6) 2011: the patient presented with routine general medical exam and with depressive disorder, low back pain and palpitation.Ros revealed: on (b)(6) 2011: neuro/psychiatric-depression, psychiatric symptoms.On (b)(6) 2011: the patient presented with low back pain and upper respiratory infection.Ros revealed: neuro/psychiatric-headache.On (b)(6) 2011: the patient presented for follow-up with complaint of lower back pain at lumbosacral junction.On (b)(6) 2011: the patient underwent ct l-spine w/o contrast.Impression: postsurgical changes from the l3 through si levels as described above.No central canal or significant neural foraminal encroachment is identified.On (b)(6) 2011: the patient presented for follow-up with solid arthrodesis.On (b)(6) 2011: the patient presented with pharyngitis and sore throat.03 jan 2012: ros revealed: neuro/psychiatric-depression, sleep disturbances.On (b)(6) 2011, (b)(6) 2012: musculoskeletal: back pain.On (b)(6) 2012: the patient presented with heel pain (plantar fasciitis), depression and wart.On (b)(6) 2012: the patient presented with back pain, depression and hypertension.On (b)(6) 2012: the patient presented with preoperative diagnosis: acute appendicitis and underwent a procedure.Ros revealed: musculoskeletal: moderate pain w/motion.On (b)(6) 2012: the patient presented with dizziness.On (b)(6) 2012: ros revealed: neuro/psychiatric-numbness, tingling in legs.On (b)(6) 2012: the patient was diagnosed with cholesterol.On (b)(6) 2012: ros revealed: neuro/psychiatric-shaking on (b)(6) 2010, (b)(6) 2012: the patient presented with flu shot.The patient underwent chest x-ray, 2 views, frontal and lateral.On (b)(6) 2011, (b)(6) 2012: the patient presented with back pain, depression and constipation on (b)(6) 2013: the psychiatric result revealed flattened affect.On (b)(6) 2013: the patient presented with back pain, excessive sweating and depression.On (b)(6) 2013: the patient presented with shoulder pain and depression.On (b)(6) 2011, (b)(6) 2012, (b)(6) 2013: the patient presented with back pain and depression.On (b)(6) 2013, ros revealed: musculoskeletal-back pain.On (b)(6) 2012, (b)(6) 2013 the patient presented with depression, back pain and insomnia.On (b)(6) 2012, (b)(6) 2013, ros revealed: neuro/psychiatric - suicidal ideation.On (b)(6) 2013: the patient presented for psychiatric evaluation.On (b)(6) 2013: ros revealed- neurological: headache on (b)(6) 2013 the patient presented with back pain and mood disorder.On (b)(6) 2012, (b)(6) 2013, ros revealed: neuro- difficulty initiating sleep.Psych-depressed mood, difficulty concentrating, feelings of guilt, marked diminished interest or pleasure.Assessment: anxiety.
 
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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
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key5044137
MDR Text Key24657070
Report Number1030489-2015-02131
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
Reporter Occupation Attorney
Report Date 08/03/2015
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 Date04/01/2012
Device Catalogue Number7510800
Device Lot NumberM110809AAE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/24/2009
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) Required Intervention;
Patient Weight122
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