BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVAL SOLID CARBIDE BUR

    MDR report key: 2705493 · Received August 9, 2012

    Report

    Report Number
    2705493
    Event Type
    Death
    Date Received
    August 9, 2012
    Date of Event
    August 7, 2012
    Report Date
    August 9, 2012
    Manufacturer
    STRYKER
    Product Code
    DZJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE COURSE OF REMOVING THE POSTERIOR COMPONENT OF THE INFERIOR NASAL TURBINATE, A 4MM BUR WAS USED ON THE LONG STEM. WHEN THE BUR BECAME DULL, IT WAS REMOVED AND EXCHANGED FOR A NEW BUR. THE NEW BUR WAS THEN USED TO FURTHER BUR DOWN THE SEPTUM AGAINST THE THICKENED HYPERTROPHIED BONE IN THE NASAL CAVITY. DURING THIS PROCESS, THE BUR HEAD SNAPPED OFF. THE BUR WAS FOUND LOOSE AND FLOATING IN THE BASE OF THE SINUS. A NEW BUR WAS USED FOR APPROX 15-30 MINS AT A DRILL DEPTH OF 5.5-6 CM. AN ACUTE HEMORRAGE BECAME APPARENT AT THIS POINT AND WAS FOUND TO BE FROM AN INTERNAL CAROTID ARTERY WHICH WAS UNRELATED TO THE SURGICAL AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OVAL SOLID CARBIDE BUR OVAL SOLID CARBIDE BUR DZJ STRYKER 1608235 *

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death