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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 7510600
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bronchitis (1752); Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Skin Irritation (2076); Tingling (2171); Microcysts, Epithelial (2232); Sinus Perforation (2277); Malaise (2359); Depression (2361); Numbness (2415); 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) 2004 patient presented for follow-up visit.The fine section cat scan showed a pseudarthrosis in the lumbar fusion.On (b)(6) 2004 patient underwent chest radiography.Summary: 1.Left lower lobe atelectasis vs.Scarring.2.Old granulomatous disease.On (b)(6) 2004 patient admitted because of a prior l5, s1 posterior fusion.Pre-operative diagnosis: pseudoarthrosis of l5-s1, poste rolateral fusion and sprain injury of lumbar spine.Per-op notes: the cage went in to disc space in a satisfactory fashion and was anterior/posterior very, very nicely.It was sunk 3mm.This was done on both sides and both cages were lined up very nicely.They were within the pedicles on the ap and were lined up very nicely on the lateral.Then rh-bmp2/acs having been prepared was packed in to the cage.The rh-bmp2/acs that was prepared was three sponges rh-bmp2/acs.Two sponges were used in one space and three sponges in to the other space.The three sponges rh-bmp2/acs, it should be noted, was prepared for the at.The extra sponge was then packed between the cages and the alignment was just excellent.The content of the cage were excellent.On (b)(6) 2004 patient presented for follow-up visit.X-rays shown excellent position of the cages and good distraction of the disc space.At this time he also complains of some numbness intermittently of the upper extremities, in the hand, as well as in the feet.On (b)(6) 2004 patient presented for follow-up visit.Patient states that he feels worse now than before surgery.On (b)(6) 2004 patient presented for follow-up visit.X-rays show the fusion mass to be solid with good continuity of bone between the l5 and s1 vertebrae right through the lt cages at this point four months after his surgery.On (b)(6) 2004, patient presented with complaints of pain and this is a very burning-like sensation in the left buttock and the front of the left thigh, as well as the back of the thigh and the calf.He also notes some right anterolateral thigh burning sensation.He states that he feels like he is doing worse after his physical therapy.X-raystoday show the fusion mass to be solid.There is a solid piece of bone going all the way through the cages from ls through s1.On (b)(6) 2004 patient presented with complaint of considerable pain in the hips and back area with some paresthesias in the left leg, which is worse at the end of the day.On (b)(6) 2006, patient presented with chief complaint of depression, chronic back pain.Assessment: hypertension improved.Depression improved.Chronic low back pain stable.On (b)(6) 2007 patient presented with sinus drainage.Frontal headache.Some bad taste in his mouth.Nonproductive cough.On (b)(6) 2008 patient presented with problem of an abscess about 0.5 cm x 0.5 cm just superior and medial to his left nipple.On (b)(6) 2008 patient presented with pain in his right shoulder.On (b)(6) 2008 patient presented with problems of cough and cold.Runny nose.Headache.Generalized malaise.Coughing up some white and yellow phlegm.The cough makes his low back or worse.On (b)(6) 2009 patient presented with disability exam.On (b)(6) 2010 patient presented with hypertension, degenerative disk disease of his low back.Depression secondary to his chronic pain.On (b)(6) 2010 patient presented with bronchitis.He is wheezing.He has had a cold for about 5 days.Low-grade fever, coughing up phlegm but is swallowing it, so does not know the color.Some tightness in his chest.On (b)(6) 2011 patient presented for medicine refill.On (b)(6) 2012 patient presented with complains of gabapentin no longer working for pain, sleep aid no longer helping him to sleep.Unable to exercise due to chronic back <(>&<)> hip pain.On (b)(6) 2012, patient presented for medicine refill.On (b)(6)2012 patient presented with preoperative diagnosis: screening colonoscopy.Procedure: patient under n sedation and in lateral decubitus position.Coion05gopc was inserted under direct vision the whole colon was examined up to cecum and no abnormal.Mucosal findings noted that might suggest polyps, carcinoma or colitis or diverticulosis.Retro flexed examination of the rectum was unremarkable except for the presence of grade i to grade ii internal hemorrhoids.Procedure was terminated and he tolerated procedure well without any complications.On (b)(6) 2012 patient admitted.Procedure: central and occipital eeg.Submental is end anterior emg, ekg, eog and oral air flow, th oraco-obdominal motion and pulse oximetry were monitored, cpap/bpap titration was done using respironics comfort full face mask.On (b)(6) 2012 patient presented with multiple complaints.He says "it feels as painful as the day i broke my back." on (b)(6) 2012 patient underwent mri l-spine w and w/o.Impression: 1.Facet arthropathy with foraminal protrusionsas described above.2.Previous anterior lumbar fusionls-s1.3.Note: post contrast imaging performed as well with gadolinium contrast.On (b)(6) 2012 patient underwent following procedure: rest/ regadenoson stress nuclear myocardial perfusion imaging study with spect.Conclusion 1 the electrocardiogram is negative for ischemia 2 normal nuclear imaging study 3.Normal rest and exercise myocardial perfusion images.4.Normal lv wall motion and systolic thickening.The left ventricle was normal in size at rest.5.The lv ejection fraction percentage is 65.6.No prior mpi.On (b)(6) 2012 patient presented underwent lexiscan stress test for myocardial perfusion imaging.Conclusion 1 the electrocardiogram is negative for ischemia 2 normal nuclear imaging study 3.Normal rest and exercise myocardial perfusion images.4.Normal lv wall motion and systolic thickening.The left ventricle was normal in size at rest.5.The lv ejection fraction percentage is 65.6.No prior mpi.On (b)(6) 2012 patient presented with swollen ankles.His left one was swollen so badly yesterday that he could not put a shoe on.On (b)(6) 2012 patient presented with chief complaint of irritated skin lesions, cysts.On (b)(6) 2012 patient presented for evaluation for weight loss surgery.On (b)(6) 2012 patient presented with complaint of non-productive cough, sinus drainage, and headache.On (b)(6) 2012 patient presented for physical examination.Review of musculoskeletal system: joint pain, restless leg, no trauma.Back pain in the lower region, the pain is severe, history of spinal fracture.Review of neurological system: numbness, tingling, no altered mental status, no abnormal balance, no atexie.No contusion.No seizure, no syncope.On (b)(6) 2012 patient presented with re-checking on bronchitis.On (b)(6)2012 patient presented with continued complaint of cough and sinus drainage.On (b)(6) 2013 patient presented with preoperative diagnosis morbid obesity with comorbidities in the form of back pain, restless leg.Operative findings: morbid obesity.No patient complications.On (b)(6) 2013 patient visited for medicine questions.
 
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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 Key5059793
MDR Text Key25109091
Report Number1030489-2015-02234
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 08/17/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510600
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received08/17/2015
Was Device Evaluated by Manufacturer? No
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 Weight153
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