BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIGEN

    MDR report key: 2940792 · Received November 15, 2006

    Report

    Report Number
    1020279-2006-00651
    Event Type
    Injury
    Date Received
    November 15, 2006
    Report Date
    November 15, 2006
    Manufacturer
    SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY UNDER EVAL.

    Description of Event or Problem · 1

    SURGICAL TIME WAS EXTENDED DUE TO BREAKAGE OF THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIGEN INSTRUMENT LXH SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. NA 01DM00723

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other