BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LLN INSTRUMENTS

    MDR report key: 2843258 · Received November 22, 2012

    Report

    Report Number
    1020279-2012-00638
    Event Type
    Injury
    Date Received
    November 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    LXH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY WAS REPORTED AS THE PIN CLAMPS WOULD NOT MOVE, THE DISTRACTOR BOWED AND DEFORMED. THE DEVICE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLN INSTRUMENTS RAIL LXH SMITH & NEPHEW, INC. 11BM16146

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4)