BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX-R "S" #20 25MM

    MDR report key: 2534692 · Received April 5, 2011

    Report

    Report Number
    2523190-2012-00039
    Event Type
    Malfunction
    Date Received
    April 5, 2011
    Report Date
    April 5, 2012
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EKJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    "FILES ARE BREAKING SAME SPOT REGARDLESS OF LOT, NOT FLEXIBLE AT ALL." ON (B)(4) 2012, ADD'L INFO WAS RECEIVED: "THE FILE BROKE INSIDE THE PT'S TOOTH AND WAS NOT ABLE TO BE RETRIEVED. NO PT INJURY OCCURRED. WHILE PERFORMING ROOT CANAL THERAPY THE 25 MM SIZE 20 FLEX-R FILES WITH STOPS SEPARATED IN A CANAL. THE FILE WAS NEW. THE DR ATTEMPTED TO REMOVE THE BROKEN SEGMENTS AND WAS UNABLE TO REMOVE THE BROKEN PIECE. AT THIS TIME THE ROOT CANALS HAVE BEEN COMPLETED AND THE PTS WILL BE MONITORED TO SEE IF ANY OTHER TREATMENT IS NEEDED. THE ENDODONTIC THERAPY COULD EVENTUALLY FAIL DUE TO THE FILES IN THE CANALS. THE PTS WILL BE RECALLED FOR RADIOGRAPHS AT 6 MONTHS, 12 MONTHS AND 24 MONTHS POST TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX-R "S" #20 25MM M50 - ENDODONTICS EKJ INTEGRA YORK, PA INC 330P1112

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR