BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 4954206 · Received July 24, 2015

    Report

    Report Number
    1419322-2015-00068
    Event Type
    Malfunction
    Date Received
    July 24, 2015
    Report Date
    June 24, 2015
    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 COMPLAINT WAS VERIFIED THROUGH PRODUCTION AND QUALITY TESTING. MAXIMUM TEMPERATURE FOR THE ATTACHMENT HEAD EXCEEDED ISO 13732-1 AND ES-1104 FOR MAXIMUM ALLOWABLE TEMPERATURE DURING TESTING. CAP END BEARING RETAINER FAILURE, FREE ROAMING BALL BEARINGS AND EXCESSIVE DEBRIS MOST LIKELY CREATED FRICTION WITHIN THE HEAD WHICH RESULTED IN TEMPERATURE INCREASE. GEAR FUNCTION WAS ALSO COMPROMISED INSIDE THE HEAD AND NECK WHICH IS EVIDENT FROM THE WEAR ON THE TEETH OF THE GEARS.

    Description of Event or Problem · 1

    IN THIS EVENT A DOCTOR REPORTED THAT AN ESTYLUS 1:5 HANDPIECE OVERHEATED WHILE IN USE. THERE WAS NO INJURY OR INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482203 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1