BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTION BUR GUARD

    MDR report key: 1379400 · Received March 4, 2009

    Report

    Report Number
    1811755-2009-00037
    Event Type
    Malfunction
    Date Received
    March 4, 2009
    Date of Event
    January 27, 2009
    Report Date
    February 3, 2009
    Manufacturer
    STRYKER INSTRUMENTS KALAMAZOO
    Product Code
    EJL
    PMA / PMN Number
    K961970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE HANDPIECE NOR THE BUR GUARD WERE SENT BACK TO THE MANUFACTURER FOR INVESTIGATION. BASED ON THE INFORMATION THAT WAS RECEIVED FROM THE ACCOUNT, THE MOST LIKELY ROOT CAUSE WAS DUE TO THE BUR GUARD BEING PUSHED UP ONTO THE NOSE CONE. WHEN THE BUR GUARD COMES INTO CONTACT WITH THE NOSE CONE, THE FRICTION CAN CAUSE THE BUR GUARD TO MELT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A WISDOM TOOTH REMOVAL, THE BURGUARD MELTED. THERE WAS NO INJURY TO THE PATIENT OR TO THE USER, ANOTHER HANDPIECE WAS AVAILABLE TO COMPLETE THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK