BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDGEFILE X7

    MDR report key: 17455622 · Received August 3, 2023

    Report

    Report Number
    3008857765-2023-00005
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 3, 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. THE EDGEFILE X7 DFU STATES THE RECOMMENDED TORQUE OF THE DEVICE TO NOT EXCEED 300 GCM. THE DENTIST USED THE DEVICE WITH A TORQUE SETTING OF 380 GCM.

    Description of Event or Problem · 0

    IN THIS EVENT IT WAS REPORTED THAT A EDGEFILE X7 ROTARY FILE 29MM BROKE DURING USE (REPORTED BY A PHONE CALL FROM THE DENTIST, DR. LANGELLA). THE FILE SEPARATED AT THE FLUTE/SHALFT JUNCTURE WHILE INSTRUMENTING ON TOOTH #24. DR. STATED THAT THIS SEPARATION WAS SURPRISING BECAUSE THIS WAS A RETREATMENT CASE SO THE TOOTH HAD ALREADY BEEN PREVIOUSLY OPENED UP. FILE SEPARATED ON FIRST PASS. THE BROKEN FILE WAS NOT ABLE TO BE REMOVED AND THE DENTIST FILLED AROUND THE FILE PORTION WITH A PERMANENT FILLING MATERIAL. CURRENTLY FOLLOW UP APPOINTMENT WITH PATIENT IS SCHEDULED FOR (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891033 EDGEFILE X7 ENDODONTIC FILE EKS US ENDODONTICS, LLC. X7250429RF 123022216

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention