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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dyspnea (1816); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
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
Pre-op diagnosis: scoliosis procedure: fusion it was reported that: on an unknown date in (b)(6) 2008, the patient was initially diagnosed with 7 degrees scoliosis.On an unknown date in 2009, patient's curvature had increased to 12 degrees.On an unknown date in 2010, patient had another analysis of her spine and her curvature had progressed to 37 degrees.On an unknown date in (b)(6) 2010, patient underwent x-ray which revealed a curvature of 41 degrees.The surgeon recommended bracing her until she finished growing which would be until the age of 18, in another 5 years.On an unknown date in (b)(6) 2010, patient went for an office visit.On (b)(6) 2011 the patient underwent spine stapling surgery using rhbmp-2/acs.Reportedly, post-op, patient had to withstand a very painful surgery, patient had increased fear of cancer.Patient continued to have pain from the surgery and also had breathing issues.On an unknown date in (b)(6) 2012, an x-ray revealed that the patient's curvature had increased and that some of the initial straightening provided by the surgery was lost.
 
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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 USA, INC
4340 swinea rd
memphis TN 38118
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6492897
MDR Text Key72779729
Report Number1030489-2017-00902
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
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received03/21/2017
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 Age14 YR
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