BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3788478 · Received April 3, 2014

    Report

    Report Number
    1419322-2014-00019
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Report Date
    March 6, 2014
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 A SIMILAR 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 DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT OUR REPAIR FACILITY REPORTED THAT A ESTYLUS 1:5 ATTACHMENT OVERHEATED WHILE TESTING; NO INJURY RESULTED AND NO INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202193 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1