BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENXOR WIRE POST

    MDR report key: 464467 · Received June 5, 2003

    Report

    Report Number
    8030968-2003-00001
    Event Type
    Injury
    Date Received
    June 5, 2003
    Report Date
    May 6, 2003
    Manufacturer
    STRYKER TRAUMA SA
    Product Code
    LXT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SURGERY TOOK PLACE IN 2003. THREE WEEKS LATER IT WAS FOUND THAT THE WIRE WAS LOOSE. PT WAS REVISED AND IT WAS FOUND THAT THE LOCKING MECHANISM OF THE WIRE POST WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TENXOR WIRE POST INSTRUMENT LXT STRYKER TRAUMA SA NA J372099

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention