BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.0 SINGLE USE DISPOSABLE ROUND DIAMOND BUR

    MDR report key: 24790 · Received July 28, 1995

    Report

    Report Number
    24790
    Event Type
    Injury
    Date Received
    July 28, 1995
    Date of Event
    January 18, 1995
    Report Date
    March 13, 1995
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS UNDERGOING SURGERY FOR COCHLEAR IMPLANTS. THE SURGEON WAS DRILLING THE MASTOID BONE WHEN THE TIP OF THE DIAMOND BUR FRAGMENTED. THIS HAPPENED WITH 2 SEPARATE BURRS. ALL OF THE PIECES OF THE BURRS WERE RETRIEVED UNDER DIRECT VISION & AN X-RAY FOR ELECTRODE PLACEMENT DID NOT SHOW ANY GROSS FRAGMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 1.0 SINGLE USE DISPOSABLE ROUND DIAMOND BUR DRILL BUR HTW MICROTEK MEDICAL, INC. UNKNOWN 3320 & 4227

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Required Intervention