BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKELL

    MDR report key: 23401745 · Received October 28, 2025

    Report

    Report Number
    2411797-2025-00002
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 10, 2025
    Report Date
    October 24, 2025
    Manufacturer
    PARKELL, INC.
    Product Code
    ELC
    UDI-DI
    00810000522927
    PMA / PMN Number
    K950256
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    WE REQUESTED IMAGES OF THE BROKEN INSERT BOTH ALONE AND IN THE PERFORMANCE GUIDE TOOL. BY REVIEWING THESE IMAGES, WE WERE ABLE TO CONCLUDE THAT THE INSERT WAS USED BEYOND RECOMMENDED PERFORMANCE GUIDELINES AS STATED IN THE IFU. MEASUREMENT IS SUGGESTED WEEKLY WHEN INSERT IS CLEAN. IF THE WEAR IS MORE THAN 3 MM THE INSERT SHOULD BE REMOVED FROM SERVICE AND REPLACED.

    Description of Event or Problem · 0

    ON OCTOBER 10TH, 2025, PARKELL BECAME AWARE OF AN INCIDENT INVOLVING OUR INSERT, DURA30-US - DURATIP® 30K UNIVERSAL SLIM INSERT. THIS INSERT IS AN ACCESSORY TO OUR TURBO ULTRASONIC SCALER. THE INSERT WAS IN USE BY A DENTAL STUDENT WHEN IT BROKE OFF IN THE PATIENT'S MOUTH. NO INJURY WAS INITIALLY REPORTED. NO TREATMENT WAS SOUGHT. THE UNIVERSITY IS KEEPING THE INSERT AND WILL NOT RETURN IT FOR EVALUATION. WE HAVE RECEIVED IMAGES OF THE INSERT BOTH ALONE AND IN OUR PERFORMANCE GUIDELINE TOOL. EVALUATING THESE IMAGES, IT IS OUR EXPERT OPINION THAT THE INSERT WAS USED BEYOND PERFORMANCE GUIDELINE REQUIREMENT OF 3 MM OF WEAR. IFU INSTRUCTION FOR PERFORMANCE GUIDELINE - IF THE END OF THE TIP DOES NOT EXTEND FULLY ACROSS THE 3 MM INDICATOR GROOVE (FIGURE 4) OR IS FLUSH WITH THE LEFT SIDE OF THE GROOVE, OR IS SHORT OF THE GROOVE, THE TIP HAS REACHED 3 MM OF WEAR AND SHOULD BE REMOVED FROM SERVICE AND REPLACED. WE ARE FILLING THIS REPORT IN AN ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352060 PARKELL INSERT ELC PARKELL, INC. DURA30-US 00810000522927

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown