BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3221705 · Received June 3, 2013

    Report

    Report Number
    1419322-2013-00025
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    June 10, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 COMPLAINT WAS VERIFIED DURING TESTING. MAXIMUM TEMPERATURE FOR THE ATTACHMENT EXCEEDED ES-1104 FOR MAXIMUM ALLOWABLE TEMPERATURE. BOTH THE BUR AND CAP END BEARING RETAINER WEAR AND EXCESSIVE DEBRIS CREATED FRICTION WITHIN THE HEAD, RESULTING IN AN INCREASE IN TEMPERATURE. IT IS REASONABLE TO SUSPECT GEAR FUNCTION WAS ALSO COMPROMISED INSIDE THE HEAD WHICH IS EVIDENT FROM THE ABRASIVE WEAR ON THE TEETH OF THE GEARS. A LACK OF LUBRICATION WAS ALSO NOTICED. ADDITIONALLY, THE ATTACHMENT FAILED ALL PRODUCTION REQUIREMENTS WITH THE EXCEPTION OF ILLUMINATION TESTING PER TN8702. ALSO, A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    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
    243901 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1