BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 1214046 · Received October 23, 2008

    Report

    Report Number
    1811755-2008-00077
    Event Type
    Malfunction
    Date Received
    October 23, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    EJL
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE HAND PIECE AND BUR GUARD WERE RECEIVED AT THE MANUFACTURER FOR TESTING, AND THE ALLEGED CONDITION OF THE BUR GUARD MELTING ONTO THE HAND PIECE WAS CONFIRMED. THE HAND PIECE PASSED THE QUALITY INSPECTION PROCEDURE ACCORDING TO SPECIFICATION. THE BUR GUARD CAN MELT IF IT IS PUSHED UP ONTO THE HAND PIECE. WHEN THIS HAPPENS, THE NOSE CONE COMES INTO CONTACT WITH THE BUR GUARD, AND THE FRICTION CAN MELT THE BUR GUARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORAL PROCEDURE, THE BUR GUARD MELTED ONTO THE NOSE CONE OF THE HANDPIECE. THERE WAS NO PT OR USER INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTION BUR GUARD BONE CUTTING INSTRUMENT AND ACCESSORIES EJL STRYKER INSTRUMENTS KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK