BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUSSELL-TAYLOR

    MDR report key: 193281 · Received October 22, 1998

    Report

    Report Number
    1020279-1998-00059
    Event Type
    Malfunction
    Date Received
    October 22, 1998
    Date of Event
    December 25, 1997
    Report Date
    September 22, 1998
    Manufacturer
    SMITH & NEPHEW, INC. ORTHOPAEDICS DIV.
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FRACTURED APPROX 8 WEEKS AFTER IT WAS INITIALLY IMPLANTED ON 12/25/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUSSELL-TAYLOR Implant LOCKING SCREW HWC SMITH & NEPHEW, INC. ORTHOPAEDICS DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other