BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER

    MDR report key: 1288363 · Received January 8, 2009

    Report

    Report Number
    1288363
    Event Type
    Malfunction
    Date Received
    January 8, 2009
    Date of Event
    December 3, 2008
    Report Date
    January 2, 2009
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT TO HAVE MULTIPLE DENTAL EXTRACTIONS. DURING THE PROCEDURE, A DENTAL DRILL WITH STRYKER INSTRUMENTS 1.6MM TAPER SIDE CUTTING CARBIDE BUR WAS BEING USED IN THE MOUTH WHEN THE DRILL BIT BROKE OFF. A SECOND STRYKER INSTRUMENTS 1.6MM SIDE CUTTING CARBIDE BUR (LOT # 311110108315017AX; EXP. DATE 11/01/2011) ALSO BROKE OFF DURING THE PROCEDURE. BOTH OF THE BROKEN DRILL BITS WERE RETRIEVED AND ALL PARTS WERE ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER BUR, DENTAL EJL STRYKER INSTRUMENTS * TAPER SIDE 311100108297017E2

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR