BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGESEQUEL SAPPHIRE

    MDR report key: 17674502 · Received September 1, 2023

    Report

    Report Number
    3008857765-2023-00009
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 22, 2023
    Report Date
    September 1, 2023
    Manufacturer
    US ENDODONTICS, LLC.
    Product Code
    EKS
    PMA / PMN Number
    N/AN/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS A RESULT OF THIS MALFUNCTION, THE POTENTIAL FOR SURGICAL INTERVENTION EXISTS TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE OR PERMANENT IMPAIRMENT OF A BODY FUNCTION AS EVIDENCED BY PREVIOUS REPORTED EVENTS WITH SIMILAR FILES. THIS EVENT, THEREFORE, IS REPORTABLE PER 21CFR PART 803.

    Description of Event or Problem · 0

    DR. WELLAND CALLED TO LET US KNOW THAT HE HAD A FILE SEPARATE WHILE INSTRUMENTING ON TOOTH #19. APPROX 5-10MM OF THE FILE REMAINS IN THE TOOTH. HE CLOSED USING "GCL2C" WILL LEAVE THE FILE IF NO PROBLEMS COME UP. IF TOOTH BECOMES A PROBLEM HE WILL REFER TO AN ENDO. THERE IS NO FOLLOW UP APPOINTMENT SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224419 EDGESEQUEL SAPPHIRE ENDODONTIC FILE EKS US ENDODONTICS, LLC. ES250425 121322064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown