BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    MDR report key: 3221707 · Received June 3, 2013

    Report

    Report Number
    1419322-2013-00023
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    June 4, 2013
    Manufacturer
    DENTSPLY PROFESSIONAL
    Product Code
    EKX
    PMA / PMN Number
    K031145
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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 COULD NOT BE REPLICATED AS THE ATTACHMENT DID NOT EXCEED MAXIMUM ALLOWABLE TEMPERATURES AND NOISE DID NOT EXCEED THE SPECIFICATION LIMIT. MICROSCOPIC EVALUATION REVEALED SLIGHT GEAR WEAR. WEAR WAS ALSO NOTICED ON THE UNDERSIDE OF CAP DUE TO CONTACT HAVING BEEN MADE WITH THE SET ASSEMBLY DURING OPERATION. CONTACT BETWEEN THESE PARTS WOULD HAVE GENERATED HEAT WHICH COULD EXPLAIN THE COMPLAINT FOR HEATING UP IN THE FIELD. ALSO, 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 INDICATION THAT INJURY OR INTERVENTION OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243907 ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT EKX DENTSPLY PROFESSIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1