BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRYKER INSTRUMENTS

    MDR report key: 345652 · Received August 2, 2001

    Report

    Report Number
    MW1022556
    Event Type
    Malfunction
    Date Received
    August 2, 2001
    Date of Event
    June 18, 2001
    Report Date
    August 2, 2001
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    EJL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE MD WAS DRILLING IN PT'S MOUTH, TIP OF DRILL BIT BROKE OFF. NO PT INJURY OR METAL RETAINED IN MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35131 STRYKER INSTRUMENTS 1.2 MM CROSS CUT FISSURE BUR EJL STRYKER INSTRUMENTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other