BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2140735 · Received June 15, 2011

    Report

    Report Number
    1811755-2011-02175
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 2011
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    DZJ
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FAILURE ANALYSIS, OVERHEATING WAS NOT DUPLICATED; THE DEVICE PERFORMED ACCORDING TO SPECIFICATIONS. HOWEVER, PREVENTIVE MAINTENANCE WAS DONE AND THE DEVICE WAS CLEANED, LUBED, ADJUSTED, AND RETURNED TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING A TOOTH EXTRACTION PROCEDURE. NO ADVERSE EVENT WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A READILY AVAILABLE REPLACEMENT DEVICE WITHOUT ANY PROCEDURE DELAY.

    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