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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 7510400
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Fever (1858); Headache (1880); High Blood Pressure/ Hypertension (1908); Muscle Spasm(s) (1966); Pain (1994); Rash (2033); Swelling (2091); Cramp(s) (2193); Ulcer (2274); Joint Swelling (2356); Neck Pain (2433); Sleep Dysfunction (2517); Abdominal Cramps (2543); Fibrosis (3167)
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) 2001, patient presented for general assessment.Her mri scan of lumbar spine from (b)(6) 2001 shows some degenerative changes.Patient is complaining of back and left leg pain following a motor vehicle accident.(b)(6) 2002, patient presented with the reports of lumbar myelography with ct from (b)(6) 2002 which showed some degenerative changes in the lumbar spine without nerve root compression (b)(6) 2002, patient returned for follow-up.She had back and leg pain (b)(6) 2002, the patient had a discharge diagnosis of degenerative lumbar disc disease and underwent discectomy at l3-4 with fusion and implants at l3-4.Following procedure was performed-anterior- lumbar discectomy and fusion, l3-l4.An 18 x 1 o mm double-barrel guide was gently tamped into place under fluoroscopic guidance.Fluoroscopy was used intermittently throughout the case, which lasted greater than an hour.Tile left side was then reamed and tapped under fluoroscopic guidance.An 18 x 20mm dowel implant was then filled with rh-bmp2/acs and screwed into place under fluoroscopic guidance.The right side was then similarly reamed and tapped, a second dowel prepared and screwed into place under fluoroscopic guidance.She had tolerated the procedure well.On (b)(6) 2002, patient presented with mri report from (b)(6) 2002.Impression : thers are post surgical changes that show no unusual features.There are very mild broad base disc protrusion at a couple of levels such as l4-s and l2-3 but these do not appear significant by this method (b)(6) 2002; on (b)(6) 2002, follow up visit and complains of pain.Plain x-ray was performed.On (b)(6) 2002, the patient presented due to chronic back pain and leg pain.She underwent alif few months back.Assessment -symptomatic lumbar degenerative disc disease, l3-4; lumbar radiculitis ; status post alif (b)(6) 2003 , patient presented with severe neck pain right side.Assessment :- fibrositis of the right trapezius muscle, patient refuses injection today (b)(6) 2003; (b)(6) 2004, patient presented for f/u of lumbar radiculopathy.Mri scan of cervical and lumbar spines from (b)(6) 2004, show satisfactory appearance of her fusion l3-4 and at c6-7 (b)(6) 2004, patient here complain with ear ache/right side headache.Complains of purulent rhinorrhea / pnd, low grade fever, facial pain and tenderness.On (b)(6) 2004, patient presented for neck pain and bilateral shoulder pain since surgery on back in 2002.On (b)(6) 2004 , patient presented for persistent sinusitis , hypertension.On (b)(6) 2004, patient underwent endoscopy , study stated that ulcers in the neo-ileim.; previous side to end ileo-colonic anastomosis of the distal ascending colon.On (b)(6) 2004 , patient presented for medical reassessment of blood work and diarrhea.On (b)(6) 2004 , patient presented with pain in left side of chest.Assessment -: chest wall pain and costochondritis.On (b)(6) 2004 , patient presented with upper abdominal pain.Assessment : reflux.23 aug 04, patient presented with ear ache and soar throat.On (b)(6) 2004 ; on (b)(6) 2004 , patient presented with pain in her right arm and patient is also having right lower back pain.Assessment :-right lateral epicondylitis or tennis elbow.On (b)(6) 2004 ; on (b)(6) 2004 , patient comes in still having drainage and hoarseness in throat, shoulder pain , headache.Has crohn's disease.Bronchitis acute (b)(6) 2004 ; (b)(6) 2004 ;(b)(6) 2004 ; (b)(6) 2004 ; (b)(6) 2005 ;(b)(6) 2005 ; (b)(6) 2005 , (b)(6) 2005 , patient presented for f/u on shingles , bp check.Assessment ; post herpatic neuralgia (b)(6) 2005 ; (b)(6) 2005 ; (b)(6) 2005 , patient comes in today for chest congestion and lower back pain.Assessment -: cough ;gerd ;pnd (b)(6) 2005; (b)(6) 2005 , patient presented with lbp.On (b)(6) 2005 , patient comes in with possible shingles on left hip (b)(6) 2005 ; (b)(6) 2005 ; on (b)(6) 2005 patient presented with welling in leg.Assessment : elevated c-reactive protein, cardiac enzymes ;crohn's disease ;edema of the legs ; uri (b)(6) 2005, patient underwent mri of lumbar spine.Result were positive for post op changes with l3-4 fusion; degenerative l4-5 disc.On (b)(6) 2005 ; (b)(6) 2005, patient presented for f/u of lumbar radiculopathy, low back pain.He underwent physical examination (b)(6) 2005 , patient presented for lumbar myelography and ct scanning evaluation ((b)(6) 2005).On (b)(6) 2005 , patient presented for back pain.Assessment :back pain ;history of disc fusion (b)(6) 2006 , patient comes in having problems sleeping and cramps in legs and headaches.Assessment :- insomnia.On (b)(6) 2006, patient presented with swollen ankle.On (b)(6) 2006, patient comes in today for sore throat with drainage for 3 to 4 days.Assessment:- acute sinusitis ;pharyngitis.On (b)(6) 2006 , patient here for follow-up visit.Assessment :- lw swelling ;hyponatremia ;elevated bp.On (b)(6) 2006 , patient underwent ecg because of edema.Impression :- the aortic valve is tri-leaflet valve and demonstrate no evidence of stenosis or insufficiency.On (b)(6) 2005 ; (b)(6) 2007 ; (b)(6) 2007 , pt.Complains of shortness of breath and cough for about 1 week.Using albuterol at home helping with sob.Sob after coughing spell.Sore throat slightly nauseated, yellow sputum production denies fever, chills, vomiting, diarrhea.Assessment ; bronchitis , sinusitis (b)(6) 2004 ; (b)(6) 2005; (b)(6) 2005 ; (b)(6) 2006 ; (b)(6) 2006; (b)(6) 2007 , patient presented for blood examination.On (b)(6) 2007 , patient presented for screening mammogram.Assessment :- benign bi-rade2.On (b)(6) 2007, patient comes in with problem of asthma.On (b)(6) 2008, patient presented with sciatica with dryness of the vaginal area from hysterectomy.On (b)(6) 2008 , mri: minimal posterior central l4-5 and l5-s1 disc protrusion is present as well as some narrowing of l4-5.Impression : post op change with minimal posterior-central l4-5 and l5-s1 disc protrusion; no evidence of spinal stenosis seen.On (b)(6) 2008 patient comes in to discuss mri.Follow-up for back pain.Mri showed that she has minimal disc protrusions, some scar tissue.Impression;- post op change with minimal.Posterior-central l4-5 and l5-s1 disc protrusion; no evidence of spinal stenosis seen (b)(6) 2008 , patient presented for f/u of lumbar radiculopathy.On (b)(6) 2008 , patient underwent medicine refill and mri.He was given omnipaque 240 contrast was injected confirming needle localization with fluoroscopy in the ap, lateral and oblique views.On (b)(6) 2008 , patient comes in with spasms in knees x several days.Assessment : uti and knee pain.Patient underwent urinalysis - di pstick.On (b)(6) 2008 , patient presented for urine culture test.On (b)(6) 2008 , patient comes in for shingles on back along with rashes ,cough and congestion.On (b)(6) 2008 , patient visited for assessment of asthma.Assessment : asthma resolved.On (b)(6) 2008; (b)(6) 2009, pt.Had shortness of breath and wheezing this morning and visited for general check up.On (b)(6) 2006; (b)(6) 2007 ;(b)(6) 2009, patient presented with acute back pain.On (b)(6) 2009, patient presented with sore throat ,sinus and headache.On (b)(6) 2010, patient presented with vomiting , diarrhea.Assessment ; gastroententis.On (b)(6) 2007 ; (b)(6) 2008 ; (b)(6) 2010, patient was examined for chronic cough , congestion.Impression : no active disease.On (b)(6) 2010 , patient presented for recheck of shingles.On (b)(6) 2010 patient underwent mri of lumbar spine.Her reports stated satisfactory postoperative changes at l3-4.On (b)(6) 2010 , patient presented with back pain going down the right leg and underwent mri lumbar spine.On (b)(6) 2010, patient underwent mri lumbar spine due to back pain.Impression : post op change with l3-4 fusion; degenerative disc narrowing with mild l5-s1 and minimal l4-5 disc protrusion.On (b)(6) 2010 , patient presented for f/u.She complained of low back pain.On (b)(6) 2011, patient presented with headache sinus.Assessment : sinusitis; shingles.On (b)(6) 2011, patient presented for annual mammogram.Impression : no evidence for malignancy.Routine annual follow-up is advised (b)(6) 2012 ,xr: l3 and 4, marked disc narrowing, vacuum disc phenomena at l5-s1 with prominent anterior spurring and advanced degenerative facet joint changes.On (b)(6) 2012, patient presented with back pain.Assessment : acute pain in the back, probably disc disease.On (b)(6) 2012, patient presented for f/u back pain.On (b)(6) 2012, patient presented for medical status assessment.Assessment : hypertension; crohn's disease; disc fusion.On (b)(6) 2012 , patient presented for cbc examination.Vit.D examination.On (b)(6) 2012, patient underwent urinalysis.On (b)(6) 2012, patient was examined using ct of pelvis /abdomen.Impression(pelvis) : postop change.No significant abnormality noted.Impression ( abdomen) :- postop change with incidental small hiatal hernia.No urinary tract abnormality seen (b)(6) 2012 , patient comes in with stomach cramps and nausea.Having trouble with her bowels.On (b)(6) 2012, patient comes in with bruise on right leg.Assessment : hematoma from rupture of a varicose vein.On (b)(6) 2012 ; (b)(6) 2013 ,patient presented with congestion , sinusitis , bronchitis.On (b)(6) 2013, patient comes in for recheck of congestion, cough and cold.Assessment : bronchitis.On (b)(6) 2013 , patient presented for pathology test.Assessment :- no granuloma, dysplasia or malignancy identified.; ulcer and crypt injury changes.On (b)(6) 2013 , patient presented with headache and stomach ulcer.Assessment :headache from medication that dr.Strohecker prescribed.On (b)(6) 2013 , patient presented with pain in left breast, no injury.Assessment : possible early mastitis.On (b)(6) 2013 , patient presented for annual mammogram.Impression : no evidence for malignancy.Routine annual follow-up is advised.On (b)(6) 2013, patient presented with shoulder pain(l).Assessment : triceps tendonitis.On (b)(6) 2013, patient presented with headache, cough, congestion.Assessment : upper respiratory infection (acute).
 
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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 Key5055676
MDR Text Key24999545
Report Number1030489-2015-02209
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7510400
Device Lot NumberMA111004C
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/04/2015
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 Weight93
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