BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN SERIES IV STEP SCREW

    MDR report key: 2253957 · Received September 14, 2011

    Report

    Report Number
    3034525-2011-00038
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 13, 2011
    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

    SURGEON REPORTS SURGERY TO REMOVE BROKEN SCREWS AND USE ILIAC CREST GRAFT FOR NONUNION. CAUSE OF BREAKAGE: NONUNION SHIFTED DISTALLY DUE TO FULL WEIGHT BEARING AND RESULTED IN INCREASED STRESS ON DISTAL SCREWS WHICH CAUSED SCREW BREAKAGE. NO INDICATION OF PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGN SERIES IV STEP SCREW INTERLOCKING SCREW HSB SURGICAL IMPLANT GENERATION NETWORK (SIGN) 084530 OR 084535 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization