BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3172366 · Received April 19, 2013

    Report

    Report Number
    1018233-2013-01407
    Event Type
    Injury
    Date Received
    April 19, 2013
    Report Date
    March 20, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADD'L INFO HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171251 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTION NA ZGI00774

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention OBTRYX