BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 1379516 · Received February 24, 2009

    Report

    Report Number
    1811755-2009-00028
    Event Type
    Malfunction
    Date Received
    February 24, 2009
    Date of Event
    January 27, 2009
    Report Date
    January 27, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    EJL
    PMA / PMN Number
    K040369
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HANDPIECE AND BUR GUARD WERE RETURNED TO THE MANUFACTURER FOR AN INVESTIGATION. THE ALLEGED CONDITION OF THE MELTED BUR GUARD WAS CONFIRMED. ACCORDING TO THE DEVICE HISTORY RECORD, THIS WAS THE FIRST TIME THAT THE HANDPIECE WAS SENT IN FOR SERVICE. THE BUR GUARD CAN MELT IF IT IS PUSHED UP ONTO THE HANDPIECE. 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 A WISDOM TOOTH REMOVAL, THE BUR GUARD MELTED ONTO THE HANDPIECE AND THE PATIENT RECEIVED A SECOND DEGREE BURN TO THE CHEEK AND LIP. A COOLING OINTMENT WAS APPLIED TO THE BURN AND THE PROCEDURE WAS COMPLETED WITH ANOTHER HANDPIECE AND BUR GUARD. THE POST-OP VISIT SHOWED THAT THE BURN WAS HEALING, IT IS UNKNOWN IF THERE WILL BE A SCAR.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK