BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORE IMPACTION DRILL

    MDR report key: 2241615 · Received September 2, 2011

    Report

    Report Number
    1811755-2011-03271
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 12, 2011
    Manufacturer
    STRYKER INSTRUMENTS 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 DEVICE WAS RECEIVED FOR EVAL; ADDITIONAL INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CORE IMPACTION DRILL WAS SENT IN FOR EVAL DUE TO OVERHEATING DURING PROCEDURES. NO ADVERSE EVENT WAS ASSOCIATED WITH THE DEVICE. THE PROCEDURES WERE COMPLETED WITH READILY AVAILABLE ALTERNATE DEVICES 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