BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX-R 'S' #20 25MM

    MDR report key: 4790480 · Received May 20, 2015

    Report

    Report Number
    2523190-2015-00025
    Event Type
    Injury
    Date Received
    May 20, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 28, 2015
    Manufacturer
    ITEGRA YORK, PA INC.
    Product Code
    EKJ
    Adverse Event
    Yes
    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 EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    ON 06/15/2015 INTEGRA COMPLETED INVESTIGATION. RESULTS- FAILURE ANALYSIS: DENTAL FILES RETURNED IN USED CONDITION, NOT SHOWING ANY UNUSUAL MARKINGS. THE FILES WERE SHOWING WEAR UPON VISUALLY INSPECTING THE FILES, IT IS NOTICED THAT SOME OF THE FILES ARE BENT AND ONE WITH A BROKEN TIP. QUALITY INSPECTOR TESTED THE BLADES FOR BEND AND TORQUE, AND THE FILES TESTED WITHIN DEFINED SPECIFICATIONS. WITHOUT KNOWING HOW MUCH PRESSURE WAS USED DURING THE PROCEDURE, THE CAUSE OF THE COMPLAINT IS UNDETERMINED. DEVICE HISTORY EVALUATION- NONCONFORMING PRODUCT REPORT/NONCONFORMING MATERIAL REPORT HISTORY: NONE, VARIANCE AUTHORIZATION/DEVIATION HISTORY NONE, ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY: THERE IS NO APPLICABLE ENGINEERING CHANGE ORDER/MANUFACTURING CHANGE ORDER HISTORY, CORRECTIVE ACTION PREVENTIVE ACTION HISTORY: NONE, HEALTH HAZARD EVALUATION HISTORY: NONE. CONCLUSION: THE COMPLAINT REPORT CANNOT BE CONFIRMED, DUE TO THE INSTRUMENT TESTING WITHIN DEFINED SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THAT 2 FILES BROKE OFF IN PATIENTS MOUTHS. PIECE COULD NOT BE REMOVED FROM ROOT CANAL, NO ILL EFFECTS SEEN. NUMBER 2 OF 2 RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328814 FLEX-R 'S' #20 25MM M50-ENDODONTICS EKJ ITEGRA YORK, PA INC. 19052

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other