BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2082674 · Received April 28, 2011

    Report

    Report Number
    1811755-2011-01481
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS EVALUATED BY THE MANUFACTURER AND THE COMPLAINT WAS DUPLICATED. THE TEMPERATURE RISE WAS FOUND TO BE DUE TO A DAMAGED SPINDLE HOUSING AND MOTOR CARTRIDGE, AND DUE TO ROTOR RUB. THEY WERE REPLACED AND THE UNIT WAS RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE OVERHEATED DURING A TOOTH EXTRACTION. THE PROCEDURE WAS COMPLETED WITH A BACK UP AND THERE WAS NO PROCEDURAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORE IMPACTION DRILL DZJ STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK