BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRIFIX PEDICLE SCREW

    MDR report key: 514400 · Received March 5, 2004

    Report

    Report Number
    1057469-2004-00004
    Event Type
    Other
    Date Received
    March 5, 2004
    Report Date
    February 26, 2004
    Manufacturer
    ENDIUS, INC.
    Product Code
    MCV
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS INSTRUMENTED WITH THE TRIFIX PEDICLE SCREW SYSTEM IN 2002. TWO YEARS POST-IMPLANTATION, THE PEDICLE SCREW BROKE. NO ADDITIONAL INFO HAS BEEN PROVIDED TO THE MFR OR THE SALES REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFIX PEDICLE SCREW PEDICLE SCREW MCV ENDIUS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Other