BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    30K FSI-SLI-1000 INSERT,PKD

    MDR report key: 20004499 · Received August 20, 2024

    Report

    Report Number
    2424472-2024-00390
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Report Date
    August 16, 2024
    Manufacturer
    DENTSPLY LLC
    Product Code
    ELC
    UDI-DI
    D003815701
    PMA / PMN Number
    K052334/K970
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE AN OVERHEATING INSERT COULD NECESSITATE MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION, THIS MALFUNCTION WOULD BE LIKELY TO CAUSE/CONTRIBUTE TO A SERIOUS INJURY SHOULD IT RECUR. AS SUCH, 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 · 0

    IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD ALLEGEDLY OVERHEATED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1066330 30K FSI-SLI-1000 INSERT,PKD SCALER, ULTRASONIC ELC DENTSPLY LLC 23173/23349 D003815701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown