BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 1983974 · Received January 11, 2011

    Report

    Report Number
    1811755-2011-00073
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 2010
    Manufacturer
    STRYKER INSTRUEMNTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE WAS RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED, AND A FOLLOW-UP REPORT WILL BE SUBMITTED IF THE RESULTS OF THE QUALITY INVESTIGATION REQUIRE ONE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HANDPIECE BEGAN OVERHEATING DURING AN ORAL SURGERY. THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL SURGICAL INSTRUMETN MOTORS AND ACCESSORIES/ATTAC DZJ STRYKER INSTRUEMNTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK