BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3203748 · Received May 30, 2013

    Report

    Report Number
    1018233-2013-02277
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    FOFRADIM PRODUCTION
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PATIENT'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
    238679 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL FOFRADIM PRODUCTION NA ZGL00206

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention AMS SPARC