BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP SCREW SYSTEM

    MDR report key: 196526 · Received November 10, 1998

    Report

    Report Number
    1020279-1998-00062
    Event Type
    Injury
    Date Received
    November 10, 1998
    Date of Event
    October 21, 1997
    Report Date
    October 29, 1998
    Manufacturer
    SMITH & NEPHEW, INC/ORTHOPAEDICS DIV.
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE SUITE ALLEGES THAT THE DEVICE, INITIALLY IMPLANTED ON SEPTEMBER 10, 1997 FAILED AND REQUIRED REVISION ON OCTOBER 21, 1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIP SCREW SYSTEM Implant INTRAMEDULLARY HIP SCREW NAIL HSB SMITH & NEPHEW, INC/ORTHOPAEDICS DIV. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Hospitalization| R