BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1212654 · Received October 24, 2008

    Report

    Report Number
    3034525-2008-00024
    Event Type
    Injury
    Date Received
    October 24, 2008
    Report Date
    August 8, 2007
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF EXPLANTED, GIVEN DATE - UNKNOWN.

    Description of Event or Problem · 1

    I.M. NAIL BROKE SIX MONTHS POST SURGERY WHICH REQUIRED SURGERY TO CORRECT. INCORRECT NAIL AND NON-UNION CAUSED BREAKAGE.

    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) 80280 000087-5-1

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R