BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEONE PLATINUM

    MDR report key: 20706048 · Received November 18, 2024

    Report

    Report Number
    3008857765-2024-00006
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 16, 2024
    Report Date
    November 18, 2024
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    UDI-DI
    00819514020721
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    N/A.

    Description of Event or Problem · 0

    FILE BROKE INSIDE THE TOOTH AND WAS NOT ABLE TO BE REMOVED. THE PATIENT WAS REFERRED TO AN ENDODONTIST FOR A CONSULT. AS OF THIS DATE OF THIS REPORT, NO ENDODODONTIC APPOINTMENT HAS OCCURRED OR BEEN SCHEDULED. AS THE MANUFACTURER, IF WE RECEIVE FURTHER UPDATES, WE WILL ADD ADDITIONAL DETAIL TO THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596131 EDGEONE PLATINUM ENDODONTIC ROTARY FILE EKS US ENDODONTICS, LLC. EOPPRI31 070822208 00819514020721

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention