BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3150022 · Received May 20, 2013

    Report

    Report Number
    1419322-2013-00014
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THOUGH (B)(4) 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 1:5 ESTYLUS ATTACHMENT REACHED 97.6 DEGREES CELSIUS AFTER ONLY 27 SECONDS OF FREE RUN TESTING, EXCEEDING ISO AND ES1104 STANDARDS FOR MAXIMUM ALLOWABLE TEMPERATURE DUE TO BUR END BEARING FAILURE, GEAR WEAR AND EXCESSIVE DEBRIS.

    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
    222914 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1