BEUDAMED
    FDA Adverse Event Other Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 7082926 · Received December 5, 2017

    Report

    Report Number
    1018233-2013-00237
    Event Type
    Other
    Date Received
    December 5, 2017
    Report Date
    January 3, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864993 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGH00136

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM | MONARC SUBFASCIAL HAMMOCK