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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
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(6) , us.: neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient underwent anterior <(>&<)> posterior fusion surgery at l4-s1 in which rhbmp-2/acs was used.Post-op, it was reported that the patient allegedly sustained unspecified injuries resulting from the procedure.No additional information has been provided.
 
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Brand Name
INFUSE BONE GRAFT
Common Device Name
FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET
Manufacturer (Section D)
MEDTRONIC SOFAMOR DANEK USA, INC
4340 swinea rd
memphis TN 38118
MDR Report Key7498464
Report Number1030489-2018-00650
Device Sequence Number16182924
Product Code NEK
UDI-Device Identifier00681490843829
UDI-Public00681490843829
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
P000058
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2005
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Attorney
Type of Report Initial
Report Date (Section B) 05/09/2018
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
Operator of Device Health Professional
Device Catalogue Number7510800
Device Lot NumberM114005AAN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2018
Initial Report FDA Received Date05/09/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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