BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3823650 · Received February 28, 2014

    Report

    Report Number
    1419322-2014-00013
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    November 25, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. AS A RESULT OF PROCESS CHANGE AND RETROSPECTIVE REVIEW WE FOUND THIS EVENT TO BE REPORTABLE. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    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
    124099 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1