BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSS-CUT FISSURE CARBIDE BUR, TAPERED

    MDR report key: 1133460 · Received August 22, 2008

    Report

    Report Number
    9616696-2008-00042
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 23, 2008
    Report Date
    July 24, 2008
    Manufacturer
    STRYKER IRELAND LTD., INSTRUMENTS DIVISION
    Product Code
    EJL
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION. LOT NUMBER OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BUR WAS BREAKING AT WELD IN AN ORAL PROCEDURE. THERE WAS NO SERIOUS INJURY REPORTED. ALL PIECES WERE REMOVED. NO ADDITIONAL MEDICATION WAS PRESCRIBED TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CROSS-CUT FISSURE CARBIDE BUR, TAPERED DEVICE DRILLS, BURRS, TREPHINES AND ACCESSORIES EJL STRYKER IRELAND LTD., INSTRUMENTS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK