BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGE FILE X7

    MDR report key: 18319980 · Received December 13, 2023

    Report

    Report Number
    3008857765-2023-00010
    Event Type
    Malfunction
    Date Received
    December 13, 2023
    Date of Event
    November 16, 2023
    Report Date
    November 20, 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

    DISTRUBITOR WAS NOT PROVIDED WITH LOT OF DEVICE. LAST TWO SHIPMENT LOTS WERE PROVIDED DURING THE INITIAL COMMUNICATION. 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. (B)(6) AT COSTAL ENDO STUDIO HAD A X7200421RF BREAK 13-14 MM FROM TIP AND BEING LEFT IN TOOTH. FOLLOW UP APPOINTMENT WILL BE (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680418 EDGE FILE X7 ENDODONTIC FILE EKS US ENDODONTICS LLC X7200421RF 120722115,120722104

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown