BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1911866 · Received November 23, 2010

    Report

    Report Number
    1811755-2010-01800
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 1, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN REC'D AT THE MFR FOR INVESTIGATION. AN EVAL WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE ROTOR WAS LODGED IN THE MOTOR. THE MOTOR AND ROTOR, ALONG WITH OTHER COMPONENTS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING A WISDOM TOOTH EXTRACTION. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL BONE CUTTING INSTRUMENT AND ACCESSORIES DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK