BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE MICRO DRILL

    MDR report key: 1894303 · Received November 4, 2010

    Report

    Report Number
    1811755-2010-01587
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 7, 2010
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE HAS BEEN RECEIVED AT THE MANUFACTURER FOR INVESTIGATION. AN EVALUATION WAS CONDUCTED AND THE COMPLAINT WAS CONFIRMED. ACCORDING TO THE INVESTIGATION DETAILS, THE MOTOR WAS CORRODED. THE MOTOR, ROTOR AND OTHER COMPONENTS WERE REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE OVERHEATED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR ADVERSE CONSEQUENCES ASSOCIATED WITH THIS EVENT. THE CUSTOMER DID NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE ABOUT THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE MICRO DRILL POWERED SIMPLE CRANIAL DRILLS, BURRS, TREPHINES, A DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK