BEUDAMED
    FDA Adverse Event Summary report: N

    HENRY SCHEIN ENDO-FLEX K-FILES 25 MM

    MDR report key: 5415679 · Received February 8, 2016

    Report

    Report Number
    3007791573-2016-00001
    Date Received
    February 8, 2016
    Date of Event
    January 4, 2016
    Report Date
    February 5, 2016
    Manufacturer
    MANI HANOI CO., LTD.
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    AS WE COULD HAVE NOT RECEIVED THE ACTUAL PRODUCT OR THE INFORMATION REGARDING ITS LOT NUMBER, WE CHOSE A LOT NUMBER WHICH POSSIBLY HAD BEEN USED. WE EXECUTED BENDING TEST & TWISTING TEST. ITEM: ENDOFLEX #10K25. LOT NUMBER ITEM LOT# R1A02500-00 =MATERIAL LOT#R14B068004. AS A RESULT OF THAT, WE CONCLUDED THAT NO ABNORMALITY HAS BEEN IDENTIFIED. THE ABOVE REPORT HAS BEEN INFORMED TO HENRY SCHEIN ON MARCH 18, 2016.

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REPORTED BY THE IMPORTER ON 11TH OF JANUARY 2016 IN RESPONSE TO A CUSTOMER COMPLAIN. POST-MARKETING SURVEILLANCE MEETING WAS HELD AND IDENTIFIED AS NOT ADVERSE EVENT BASED ON THE PRODUCT RELATED TO THE EVENT WAS NOT LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY. TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED, AND CANNOT CONDUCT EVALUATION. ALSO LOT NUMBER IS NOT AVAILABLE. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    AN IMPORTER REPORTED THAT WHILE A DENTIST WAS PERFORMING A ROOT CANAL PROCEDURE WITH K-FILE, IT BROKE AND GOT STUCK INSIDE THE PATIENT'S CANAL. THE DENTIST TOOK AN X-RAY AND WAS UNABLE TO RETRIEVE THE FILE; THEREFORE, THE PATIENT WAS REFERRED TO AN ORAL SURGEON TO HAVE IT REMOVED. THE BROKEN FILE WAS SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75409 HENRY SCHEIN ENDO-FLEX K-FILES 25 MM FILE, PULP CANAL, ENDODONTIC EKS MANI HANOI CO., LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other