BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAG SCREW

    MDR report key: 2033200 · Received March 15, 2011

    Report

    Report Number
    2033200
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 15, 2011
    Manufacturer
    SMITH & NEPHEW
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT SUFFERED A FX OF THEIR LEFT FEMORAL HEAD THAT WAS REPAIRED WITH A PLATE AND SCREW IMPLANT. SUBSEQUENT TO THE REPAIR SHE FELL AT HOME. NON-UNION WITH A BROKEN LAG SCREW WERE IDENTIFIED. SCREW AND OTHER HARDWARE WERE SUBSEQUENTLY REMOVED. A SMITH & NEPHEW #12, +4 NECK, 46 MM UNIPOLAR HEAD WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAG SCREW LAG SCREW HWC SMITH & NEPHEW * 05HT91906

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR