BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOSEQUENCE ROTARY FILE

    MDR report key: 5624328 · Received May 2, 2016

    Report

    Report Number
    1032227-2016-00004
    Event Type
    Injury
    Date Received
    May 2, 2016
    Date of Event
    January 11, 2016
    Report Date
    March 4, 2016
    Manufacturer
    FKG DENTAIRE SA
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    SD, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE CUSTOMER NOTED THAT THE FILE BROKE IN THE PATIENT'S CANAL AND WAS NOT ABLE TO BE RETRIEVED. NO PRODUCT HAS BEEN RETURNED FOR EXAMINATION OR TO IDENTIFY LOT NUMBER. UNABLE TO DETERMINE CAUSE. FILES CAN BREAK IF THE CANAL HASN'T BEEN PROPERLY PREPPED, IF THE FILE BINDS, IF THE SPEED OR TORQUE IS TOO HIGH, OR THE INCORRECT INSTRUMENT IS USED.

    Description of Event or Problem · 1

    CUSTOMER STATED THAT THE ROTARY FILE BROKE IN THE CANAL. SIZE 30 AND 35. BOTH 04 TAPER. 25MM LENGTH THE BROKEN FILES WERE NOT ABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278585 ENDOSEQUENCE ROTARY FILE ENDODONTIC ROTARY FILE EKS FKG DENTAIRE SA SEQ RF35 04 25 16MM RS 4P NITI RA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Disability