BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGN SERIES IV STEP SCREW

    MDR report key: 1944428 · Received December 17, 2010

    Report

    Report Number
    3034525-2010-00025
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 2010
    Manufacturer
    SURGICAL IMPLANT GENERATION NETWORK (SIGN)
    Product Code
    HSB
    PMA / PMN Number
    K022632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    SURGEON REPORTS AN INDICATION FOR SURGERY DUE TO INFECTION. DURING EXAMINATION X-RAY SHOWS DISTAL SCREW BROKEN. CAUSE OF INFECTION UNKNOWN. SERIES IV STEP SCREW BROKE DUE TO NONUNION SHIFTING DISTALLY UNDER FULL WEIGHT BEARING. 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) UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization