BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 4250264 · Received November 6, 2014

    Report

    Report Number
    1419322-2014-00073
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Report Date
    October 7, 2014
    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. BUR END BEARING RETAINER FAILURE, FREE ROAMING BALL BEARINGS AND EXCESSIVE DEBRIS MOST LIKELY CREATED 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 ABRASIVE WEAR ON THE TEETH OF THE GEARS. ROOT CAUSE CODE: SET/TAIL/HEAD ASSEMBLY, EXCESSIVE USE/ABUSE.

    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
    714285 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1