9/14/2015 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  Injury   Manufacturer Narrative (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 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. In addition to the narrative provided above, which pertains specifically to the patient and event described in this report, we are providing the summary report as follows: exemption report number (b)(4) total number of remaining events summarized in the exemption report: (b)(4) the events summarized pertain to a retrospective post­market study that was conducted for the infuse bone graft product. The study was conducted in the 2006­2008 timeframe, and included data from the 2002­2006 timeframe, but was discontinued before it was completed. These events were not reported through a clinical study submission or previously assessed for mdr reportability.   Event Description It was reported that the patient underwent a tlif l3­4 with posterolateral fusion and pedicle screw fixation to treat degenerative d isk disease with spinal stenosis l3­4 degeneration using rhbmp­2/acs, local bone, pedicle screws and rods. The bmp was placed outside implant (posterolateral gutters). Nineteen months post op, the patient developed an infection at the implant and surgical site. The infection was moderate and assessed to be related to the implant and procedure. The patient underwent reoperation, irrigation and debriment nineteen months post op. The patient was last seen in follow up at twenty months where bone fusion was assessed as ¿undetermined¿.   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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3650045 1/4 9/14/2015 MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MO… 90139631 9013963133 MDR Report Key3650045 Report Number1030489­2014­00628 Device Sequence Number1 Product CodeNEK25 Report SourceManufacturer Source TypeStudy,Health Professional Reporter OccupationPhysician Type of ReportInitial Report Date04/20/2007 1 Device Was Involved in the Event 1 Patient Was Involved in the Event Date FDA Received02/27/2014 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 Received04/20/2007 Was Device Evaluated By No Answer Provided 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: 02/27/2014 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 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3650045 2/4 9/14/2015 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 Page Last Updated: 08/31/2015 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. 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