10/1/2015 MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MO… MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE FDA Home3 Medical Devices4 Databases5 BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET 510(k) 7 DeNovo8 Registration & 6 Listing9 CFR Title Radiation­Emitting 2116 Products17 Adverse Recalls11 PMA12 HDE13 Classification14 Standards15 Events10 X­Ray Medsun Assembler 18 Reports19 CLIA20 TPLC21 Inspections22 MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, Back to RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD Search WITH MET Results Catalog Number 7510200 Event Type  Death   Manufacturer Narrative Unable to determine date of death. (b)(6). (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. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices contributed to the reported event, we are filing this mdr for notification purposes. This mdr is late since the source data for this mdr is from a retrospective study that was conducted in 2006­ 2008 which included data from 2002­2006. The adverse events in this dataset were not assessed for reportability until june 2013. (b)(4).   Event Description It was reported that the patient underwent left si joint fusion using rhbmp­2/acs, iliac crest bone graft, and a titanium spinal fusion cage. The bmp was placed both inside and outside the implant. The patient¿s last follow up exam was performed at 15 months, and the bone healing was assessed as ¿healed/fused. ¿ 22 months post­op, the patient died. The cause of death was reported to be breast cancer, and the death was assessed by the investigator as not related to the surgery or the devices.   Search Alerts/Recalls23   New Search     Submit an Adverse Event Report24 Brand NameINFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC Type of Device 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 ContactHuzefa Mamoola 1800 Pyramid Place Memphis , TN 38132 (901) 901 ­9013 90139631 9013963133 MDR Report Key3248407 Report Number1030489­2013­03113 Device Sequence Number1 Product CodeNEK25 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3248407 1/4 10/1/2015 MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MO… Report SourceManufacturer Source TypeStudy,Health Professional Reporter OccupationPhysician Type of ReportInitial Report Date07/22/2007 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received07/25/2013 Is This An Adverse Event Report?Yes Is This A Product Problem No Report? Device OperatorHealth Professional Device Catalogue Number7510200 Was Device Available For No Evaluation? Is The Reporter A Health Yes Professional? Date Manufacturer Received07/22/2007 Was Device Evaluated By No Manufacturer? Is The Device Single Use?Yes Is this a Reprocessed and Reused No Single­Use Device? Type of Device UsageInitial Patient TREATMENT DATA Date Received: 07/25/2013 Patient Sequence Number: 1 Links on this page: 1.  http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain 2.  http://www.addthis.com/bookmark.php 3.  http://www.fda.gov/default.htm 4.  http://www.fda.gov/MedicalDevices/default.htm 5.  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 6.  /scripts/cdrh/devicesatfda/index.cfm 7.  /scripts/cdrh/cfdocs/cfPMN/pmn.cfm 8.  /scripts/cdrh/cfdocs/cfpmn/denovo.cfm 9.  /scripts/cdrh/cfdocs/cfRL/rl.cfm 10.  /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm 11.  /scripts/cdrh/cfdocs/cfRES/res.cfm 12.  /scripts/cdrh/cfdocs/cfPMA/pma.cfm 13.  /scripts/cdrh/cfdocs/cfHDE/hde.cfm 14.  /scripts/cdrh/cfdocs/cfPCD/classification.cfm 15.  /scripts/cdrh/cfdocs/cfStandards/search.cfm 16.  /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm 17.  /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3248407 2/4 10/1/2015 MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MO… 18.  /scripts/cdrh/cfdocs/cfAssem/assembler.cfm 19.  /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm 20.  /scripts/cdrh/cfdocs/cfClia/Search.cfm 21.  /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm 22.  /scripts/cdrh/cfdocs/cfTPLC/inspect.cfm 23.  http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm 24.  https://www.accessdata.fda.gov/scripts/medwatch/ 25.  ../cfPCD/classification.cfm?start_search=&ProductCode=NEK Page Last Updated: 08/31/2015 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration 10903 New Hampshire Avenue  Silver Spring, MD 20993  Ph. 1­888­INFO­FDA (1­888­463­6332) Contact FDA             For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: 1.  http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain 2.  http://www.addthis.com/bookmark.php 3.  http://www.fda.gov/default.htm 4.  http://www.fda.gov/MedicalDevices/default.htm 5.  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 6.  /scripts/cdrh/devicesatfda/index.cfm 7.  /scripts/cdrh/cfdocs/cfPMN/pmn.cfm 8.  /scripts/cdrh/cfdocs/cfpmn/denovo.cfm 9.  /scripts/cdrh/cfdocs/cfRL/rl.cfm 10.  /scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm 11.  /scripts/cdrh/cfdocs/cfRES/res.cfm 12.  /scripts/cdrh/cfdocs/cfPMA/pma.cfm 13.  /scripts/cdrh/cfdocs/cfHDE/hde.cfm 14.  /scripts/cdrh/cfdocs/cfPCD/classification.cfm https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3248407 3/4 10/1/2015 MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MO… 15.  /scripts/cdrh/cfdocs/cfStandards/search.cfm 16.  /scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm 17.  /scripts/cdrh/cfdocs/cfPCD_RH/classification.cfm 18.  /scripts/cdrh/cfdocs/cfAssem/assembler.cfm 19.  /scripts/cdrh/cfdocs/Medsun/searchReportText.cfm 20.  /scripts/cdrh/cfdocs/cfClia/Search.cfm 21.  /scripts/cdrh/cfdocs/cfTPLC/tplc.cfm 22.  /scripts/cdrh/cfdocs/cfTPLC/inspect.cfm 23.  http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/default.htm 24.  https://www.accessdata.fda.gov/scripts/medwatch/ 25.  ../cfPCD/classification.cfm?start_search=&ProductCode=NEK https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3248407 4/4