BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3823641 · Received February 28, 2014

    Report

    Report Number
    1419322-2014-00006
    Event Type
    Malfunction
    Date Received
    February 28, 2014
    Report Date
    January 15, 2014
    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 A PROCESS CHANGE AND RETROSPECTIVE REVIEW WE FOUND THIS EVENT TO BE REPORTABLE. EVALUATION OF THE DEVICE FOUND EXPECTED NORMAL WEAR. THE DEVICE WAS REPAIRED AND RETURNED TO THE CUSTOMER. A DHR REVIEW WAS CONDUCTED WITH NO DISCREPANCIES NOTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124029 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT HANDPIECE, DIRECT DRIVE, AC-POWERED EKX DENTSPLY PROFESSIONAL NA

    Patients

    Seq Age Sex Outcome Treatment
    1