BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 2891290 · Received November 28, 2012

    Report

    Report Number
    1419322-2012-00047
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Report Date
    November 1, 2012
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PRECLUDE A SERIOUS INJURY IN THIS EVENT, THERE HAVE BEEN PREVIOUSLY REPORTED EVENTS INVOLVING THIS DEVICE THAT RESULTED IN THE NEED FOR MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. THE MAXIMUM TEMP OF 44.8 DEGREES CELSIUS WAS REACHED DURING FREE RUN TESTING. THIS TEMP LEVEL EXCEEDS THE MAXIMUM ALLOWABLE TEMP OUTLINED IN ENGINEERING SPEC 1104. ALTHOUGH THE EXTERIOR OF THE HAND PIECE DID NOT SHOW ANY MAJOR SIGNS OF WEAR, MICROSCOPIC EVAL REVEALED SLIPPAGE MARKS WITHIN THE MESHING AREA OF THE GEARS ON THE HEAD-TAIL AND HEAD ASSEMBLIES AND CRUMBLING OF THE CAP UPON REMOVAL. THESE OBSERVATIONS WERE THE MOST LIKELY CAUSE OF THE HEATING OF THE ATTACHMENT HEAD. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT AN STYLUS 1:5 HAND PIECE OVERHEATED. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1