BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1210726 · Received October 23, 2008

    Report

    Report Number
    3034525-2008-00010
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    May 11, 2007
    Report Date
    May 24, 2007
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I.M. NAIL BREAKAGE 14 MONTHS POST SURGERY. THE CAUSE FOR THE BREAKAGE WAS IDENTIFIED AS NON-UNION COMPLICATED BY THE PT FALLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN I.M. NAIL STANDARD I.M. NAIL HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) 90340 INV-149-IMP-173-90340

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R