BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 2860042 · Received October 31, 2012

    Report

    Report Number
    1419322-2012-00040
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Report Date
    October 10, 2012
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 BUR END BEARING FAILURE, FREE ROAMING BALL BEARINGS AND EXCESSIVE DEBRIS MOST LIKELY CREATED SUBSTANTIAL FRICTION WITHIN THE HEAD WHICH RESULTED IN TEMPERATURE INCREASE. IT IS REASONABLE TO SUSPECT GEAR FUNCTION WAS COMPROMISED BY THE ADDED DEBRIS INSIDE THE HEAD WHICH IS EVIDENT FROM THE ABRASIVE WEAR ON THE TEETH AND OUTER SURFACE OF THE GEARS. A LACK OF LUBRICATION WAS ALSO NOTICED AS RECEIVED.

    Description of Event or Problem · 1

    IN THIS EVENT, A DOCTOR REPORTED THAT AN ESTYLUS 1:5 HANDPIECE 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