BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSEQUENCE

    MDR report key: 6892970 · Received September 26, 2017

    Report

    Report Number
    9680913-2017-00001
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Date of Event
    July 24, 2017
    Report Date
    September 21, 2017
    Manufacturer
    FKG DENTAIRE SA
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE NOT RETURNED FOR EVALUATION AS THE DENTIST HAS NOT KEPT THEM. DHRS WERE REVIEWED AND NO ANOMALIES THAT MAY HAVE POSSIBLY CAUSED THESE BREAKAGES WERE FOUND AND FURTHER DISCUSSION WITH THE DENTIST HAS NOT PERMITTED TO IDENTIFY THE ROOT CAUSE EITHER. SUCH COMPLAINTS WILL BE TRACKED TO FOLLOW THEIR TREND.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT 2 FILES BROKE OFF (SIZE 40 AND 25), EACH INVOLVING A SEPARATE PATIENT, REASON FOR WHICH THIS IS THE FIRST OF 2 REPORTS FOR THIS EVENT. IN BOTH CASES, A FILE BROKE OFF IN THE PATIENT'S MOUTH AND IS STILL LODGED IN A CANAL OF THE TREATED TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674894 ENDOSEQUENCE ENDODONTIC FILE EKS FKG DENTAIRE SA SEQ MED RF 04 25 ASST 34678

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other