BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN I.M. NAIL

    MDR report key: 1212656 · Received October 24, 2008

    Report

    Report Number
    3034525-2008-00022
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 13, 2006
    Report Date
    October 4, 2006
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    I.M. NAIL BROKE ONE YEAR POST SURGERY REQUIRING REPLACEMENT SURGERY. DR.'S REVIEW OF THE SURGICAL RECORDS DETERMINED THE CAUSE TO BE NON-UNION COMPLICATED BY USE OF CERCLAGE WIRES WHICH DEVASCULARIZED THE BONE.

    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) 80340 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R