BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEGION

    MDR report key: 2022737 · Received March 17, 2011

    Report

    Report Number
    1020279-2011-00085
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SMITH & NEPHEW, INC
    Product Code
    LXH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE FRACTURED DURING USE EXTENDING SURGERY TIME 30- 60 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEGION LGN OFF COUPLER TRL ANGLED LXH SMITH & NEPHEW, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization