BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM

    MDR report key: 3152190 · Received May 16, 2013

    Report

    Report Number
    1018233-2013-02033
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    April 16, 2013
    Manufacturer
    SOFRADIM PRODUCTIONS
    Product Code
    FTL
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    (B)(4). THE PT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED. ASSOCIATED MDR 1018233-2013-02034.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216527 AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM FTL SOFRADIM PRODUCTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM| BOSTON SCIENTIFIC OBTRYX