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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 7510200
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Diarrhea (1811); Dyspnea (1816); Headache (1880); High Blood Pressure/ Hypertension (1908); Incontinence (1928); Nausea (1970); Neuropathy (1983); Pain (1994); Loss of Range of Motion (2032); Swelling (2091); Vomiting (2144); Tingling (2171); Distress (2329); Numbness (2415); Neck Pain (2433); Sweating (2444); Sleep Dysfunction (2517)
Event Type  Injury  
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.
 
Event Description
It was reported that on: (b)(6) 2000: the patient underwent x-rays of the chest due to hemoptysis.Impressions: no acute or active pulmonary disease suspect.(b)(6) 2002: the patient underwent x-ray of chest due to worsening dyspnea on exertion, chest pain and cough.Impression: there was no evidence for acute cardiopulmonary disease.(b)(6) 2002: the patient underwent x-ray of chest due to history of congestive heart failure.Impression: chest unchanged from (b)(6), 2002.The heart size is normal and the lungs are clear.The ascending aorta continues to be prominent.(b)(6) 2006: the patient presented with a chief complaint of radicular back pain.It was discovered that she had an l4-ls herniated disc.(b)(6) 2006: the patient presented with a chief complaint of low back pain with radicular symptoms, depression/ anxiety for which the patient got admitted.Mri films were obtained from a previous evaluation which demonstrated an l4 and l5 disc herniation.(b)(6) 2006: the patient presented with pre-op diagnosis of right l4-l5 herniated disk complaining of severe back pain and radicular pain on the right side.She was found to have an extruded disk of l4-l5 on the right.For which patient underwent right l4-l5 hemilaminectomy, foraminotomy, and microdiskectomy.(b)(6) 2006: the patient got discharged with following primary discharge diagnoses: 1.L4-l5 disc herniation status post hemilaminectomy.2.Post-traumatic stress disorder.3.Panic disorder.4.Depressive disorder.Secondary discharge diagnoses: 1.History of idiopathic cardiomyopathy.2.Hypertension.3.Asthma.4.Dyslipidemia.(b)(6) 2006: the patient presented with pre-op diagnosis of recurrent l4-l5 right herniated disc.For which patient underwent 1.Reopening of l4-l5 laminectomy and exploration.2.Revision and resection of recurrent l4-l5 hernia.(b)(6) 2006: the patient got discharged with discharge diagnosis status post right l4-5 reoperation l4-5 microdiskectomy.(b)(6) 2006: the patient presented with pre-op diagnosis of right l4-l5 recurrent herniated disk and scar tissue.For which the patient underwent right l4-l5 reopening of hemilaminectomy, revision of hemilaminectomy, scar tissue debridement and recurrent herniated disk resection.(b)(6) 2006: the patient got discharged with following discharge diagnosis: 1.Re-herniated l4, l5 disk.2.Chronic diarrhea and abd ominal pain.3.Post-traumatic stress disorder.(b)(6) 2007: patient presented for a follow-up visit complaining of pain in both legs now and severe low back pain.Recently, she had an mri and ct scan that showed severe degeneration of disc at l4-l5.(b)(6) 2007: patient underwent urinalysis.(b)(6) 2007: patient underwent beta hcg, serum test.(b)(6) 2007: the patient presented with pre-op diagnosis of ls-s1 discogenic pain.For which the patient underwent following procedures: 1.L5 laminectomy and resection of spinous process.2.L5-s1 microdiskectomy and bilateral foraminotomy.3.L5-s1 interbody fusion with a peek cage.4.S1 bilateral pedicle screw fixation.5.L5-s1 posterior fusion with autologous bone graft and bone morphogenetic protein.Per op notes, surgeon performed bilateral foraminotomies and then retracted the medial thecal sac and identified the intravertebral disk of l5-s1.The disk was also collapsed and with the legacy instrumentation for a lumbar fusion, surgeon proceeded to distract it and reopen the space between l5 and s1.Then, surgeon inserted a bmp and an autologous bone graft and then the peek cage for interbody fusion.Surgeon proceeded therefore, to apply the rods on the pedicle screws and they compacted the screws before tightening the set screw.The high speed drill was used to decorticate the posterior element on the left side of the l5-s1 and to apply more bmp and bone graft for posterior fusion.The patient tolerated the procedure well and no patient complications were noted.Patient's intra-op ap and lateral views of lumbosacral junction were obtained which revealed interbody cage and the pedicle screws at l4-l5 were anatomically aligned.(b)(6) 2007: the patient underwent ct of lumbar spine without contrast status post fusion.Impression: status post anterior and posterior fusion at l4-ls.The hardware was normally aligned.(b)(6) 2007: the patient got discharged with following discharge diagnosis: 1.L5-s1 degenerative disc disease status post lumbar fusion.2.Depression and anxiety.3.Post-traumatic stress disorder.4.Coronary artery disease.5.Hypertension.6.Asthma.(b)(6) 2007: the patient presented with complaint of exacerbated pain as she fell on her bottom status post lumbar fusion few weeks ago.Pain was located in low back and in left hip and down the right leg.Also in neck area.Numbness and tingling was still in right leg.Pain was severe and constant.Patient stated her pain was not better since preop.Impressions: back pain and x-ray of lumbar spine showed no displacement of cage.The patient also obtained ap and lateral views of lumbar spine post-op.Impression: postoperative examination without displacement.(b)(6) 2007: the patient presented with complaint of still having low back pain radiating to left buttock and leg and diarrhea.For which patient also obtained ap and lateral views of lumbar spine.Impression: status post posterior fusion.(b)(6) 2008: the patient presented with constant pain on low back right leg/foot and up to the neck.She feels that she has no coordination on right side at all.Mostly pain on leg.Impression: left leg pain; back pain.(b)(6) 2008: the patient underwent x-ray of lumbar spine due to lower back pain.Impression: stable appearance of lower lumbar spine status post l5-s1 fusion.(b)(6) 2008: the patient underwent mri of lumbar spine.Impression: patient status post bilateral laminectomy.There is a transitional vertebral segment.There is a sacralized l5 vertebral body and the surgical level is centered at the l4-l5 disc.There is minimal disc material and granulation tissue (mixed) extending into the base of the left foramen.This material approaches the base of the exiting l4 nerve root, although there is no evidence of nerve root contact or compression.There is marked improvement in right lateral recess stenosis.Degenerative disc disease at l3-l4 with mild narrowing of the right lateral recess and right foramen, without compromise of the exiting l3 or descending l4 nerve root.(b)(6) 2008: the patient presented for f/u after recent mrl of lumbar spine.Patient reported of still having severe right leg pain that radiates into her back and upper thoracic area.She had extreme tenderness in the back area also.She had paresthesias and stated she cannot feel her leg well.Impression: leg pain, right; hypertension.(b)(6) 2009: the patient underwent tetanus vaccination.(b)(6) 2011: the patient underwent x-rays of abdomen due to history of abdominal distention.Impression: no acute abnormality.Patient also underwent x-ray of chest due to chest pain.Impression: no acute cardiopulmonary disease.(b)(6) 2011: the patient presented today w/ cp accompanied at times by sob that radiates down the left arm.Patient also suffers from chronic depression-anxiety.(b)(6) 2011: the patient underwent pulmonary function test which revealed mild restrictive ventilatory defect.The patient also underwent pa and lat exam of chest due to shortness of breath and cough for a month.Impression: no active intrathoracic process or significant interval change was appreciated radiographically.(b)(6) 2011: the patient presented for a visit with complaint of right knee pain for several days since falling down some stairs, swelling hands and feet and pain at base of right thumb.Assessment: essential hypertension; joint pain, hand; knee pain; headache; chest pain; dyspnea.(b)(6) 2011: the patient presented for a visit having atypical chest pain that was reproducible with palpation but also relieved with nitroglycerin.Her ekg showed non-specific abnormalities that were stable from prior studies.Impression: chest pain (b)(6) 2011: the patient underwent x-rays of knee as she fell down flight of stairs three days ago and was having pain throughout the entire right knee.Impression: 1.No acute bony abnormality.2.Mild degenerative changes of both medial and lateral knee joint compartments.Patient also underwent x-rays of left hand which revealed no fracture, dislocation, or other bony abnormality.(b)(6) 2011: the patient presented for a follow-up visit with complaint of hypertension, vomiting and diarrhea for 3 weeks, complaint of stomach and back pain.Assessment: essential hypertension; nausea and vomiting; diarrhea; iron deficiency anemia, unspecified; carpal tunnel syndrome.(b)(6) 2011: the patient presented for a follow-up visit which included asthma exacerbation.(b)(6) 2011: the patient underwent x-rays of the chest.Impressions: the findings are most likely consistent with aninfiltrate in the lower lobe, possibly on the right side, with effusion.(b)(6) 2011: the patient presented for influenza immunization, asthma.Patient stated that she had attacks multiple times/day.Current asthma symptoms include chest tightness, intermittent cough, exercise limitation and nocturnal awakening due to shortness of breath.(b)(6) 2011: the patient presented for follow-up of an enlarged uterus and irregular bleeding.Impression: asymptomatic pelvic mass; prolonged progressive, unrelenting heavy irregular bleeding, probably an ovulatory.Embs x 2 showed no neoplasia.But at increased risk for hyperplasia and endometrial cancer; progressive.Unrelenting and incapacitating dysmenorrhea; obesity; idiopathic cardiomyopathy; fibromyalgia; coronary artery disease; hypertension; depression; asthma.(b)(6) 2012: the patient presented for a follow-up visit requesting refill on all medications.Patient also complained of asthma, vomiting and diarrhea, of hot flashes and profuse sweating.Patient's right foot also had been swelling up.(b)(6) 2012: the patient presented for a follow-up visit following a transition of care from an inpatient hospital.Assessment: essential hypertension; headache; asthma.(b)(6) 2012: the patient presented for a follow-up visit with complaint of neck pain which radiates down right arm and hypertension.Assessment: essential hypertension; herniated cervical disc; iron deficiency anemia; gerd.(b)(6) 2012: patient underwent mri of cervical spine due to cervical disc displacement.Impression: multilevel degenerative changes; foraminal compromise was present bilaterally at c3-4, c4-5 greater on the left, c5-6 where there is a disc protrusion contributing to the right foraminal compromise and at c6-7 greater on the left.There was no definite change in these findings compared to the previous study.No evidence of cord compression or intraspinal lesion.(b)(6) 2012: the patient presented for a follow-up visit with complaint of neck pain.Assessment: degenerative disc disease; essential hypertension; depressive disorder not elsewhere classified.(b)(6) 2012: the patient presented for a follow-up visit with hypertension.Patient continues with migraines.Assessment: essential hypertension mild crf; dilated cardiomyopathy; degenerative disc disease; abdominal or pelvic mass.(b)(6) 2012: the patient underwent right lower extremity venous duplex examination.Impression: patent right lower extremity venous system.No evidence of acute deep venous thrombosis.Patient also underwent urology.Impressions: poorly controlled marked hypertension; pt at risk for an acute neurological event.H/o symptomatic pelvic mass; complaints of urinary incontinence.(b)(6) 2012: the patient presented with complaint of left breast infection.Impression: probable infected sebaceous cyst/ cellulitis.(b)(6) 2012: the patient presented for dysmenorrhea.Patient stated that her menstrual cycles were still irregular.She complained of worsening pelvic pain and complete urinary incontinence.Impression: possible neurogenic bladder; new onset right le edema, pain, and tenderness.(b)(6) 2013: the patient underwent ct of cervical spine which was compared with the one dated 12 jul 2012.Impression: 1.Posterior osteophytosis from c3-c7.Findings are contributing to right bony neural foraminal stenosis from c3-c5 and left c4-c7.2.Reversal of the normal lordotic cervical spine accentuating underlying degeneration.The patient also underwent thyroid ultrasound due to indication of fullness in neck, goiter.Due to which real time sonography of the thyroid gland was performed.Impression: mild thyromegaly; three tiny benign colloid cysts in the thyroid gland.These required no further follow-up or intervention.The patient also underwent radiology of lumbar spine due to backache.Impression: 1.Hardware in place at the l4-5 level the lumbar spine.The hardware was intact.2.Sacralization of the l5 vertebral body.There is pseudoarthrosis of the right l5 lateral mass with the right s1 level which could be a source of pain.3.Minimal grade 1 anterolisthesis of l3 on 4 measuring approximately 2 mm.4.Mild multilevel end plate degeneration from l1-l4.(b)(6) 2013: the patient underwent x-rays of chest due to chest pain.Impressions: unremarkable chest.(b)(6) 2013: the patient underwent pelvis anteroposterior exam.Impression: no acute fracture or dislocation appreciated.Patient also underwent ultrasound of pelvis.Impression: limited study.Fibroid uterus.Large right ovary.Non-visualized left ovary.(b)(6) 2013: the patient underwent ct scan of head and cervical spine without contrast status post trauma, right head to drywall.Impression: head: 1.No intracranial hemorrhage, calvarial fracture, or other acute pathology is demonstrated.2.Intracranial atherosclerosis.Cervical spine: 1.No acute fracture or subluxation is demonstrated.2.Multilevel degenerative changes, as above.3.Carotid atherosclerotic vascular disease.The patient also underwent ct of thorax, abdomen and pelvis with iv contrast.Impression: 1.No ct evidence of acute traumatic injury within the thorax, abdomen and pelvis.2.Foci of enhancement in the left breast with the largest being in the upper inner quadrant measuring 24 x 30 x 18 mm.These were nonspecific, however, an underlying malignancy cannot be excluded and outpatient mammography was recommended.3.Scattered pulmonary nodules measuring 4 mm or less.The patient also underwent imaging of humerus, shoulder and complete elbow.Impression: no acute findings.(b)(6) 2014: the patient underwent single-view of chest due to shortness of breath.Impression: no active lung disease no acute changes.
 
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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 Key5042849
MDR Text Key24655889
Report Number1030489-2015-02125
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
Date FDA Received08/31/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/01/2010
Device Catalogue Number7510200
Device Lot NumberM110701AAD
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/03/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/29/2007
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 Weight94
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