BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G90 BUILT IN S/M NO XFRMR-P&C

    MDR report key: 8961607 · Received September 4, 2019

    Report

    Report Number
    2424472-2019-00136
    Event Type
    Malfunction
    Date Received
    September 4, 2019
    Report Date
    September 4, 2019
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    PMA / PMN Number
    K052334
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    WHILE NO SERIOUS INJURY RESULTED IN THIS EVENT, THERE HAS BEEN A PREVIOUS REPORT RECEIVED WHERE AN OVERHEATING INSERT RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE IS BEYOND USEFUL LIFE.

    Description of Event or Problem · 1

    WHILE USING A CAVITRON G90 OEM ULTRASONIC SCALER, THE HANDPIECE AND INSERT WERE OVERHEATING; NO INJURY RESULTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755273 G90 BUILT IN S/M NO XFRMR-P&C SCALER, ULTRASONIC ELC DENTSPLY LLC G90 NA

    Patients

    Seq Age Sex Outcome Treatment
    1