BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCHEIN K-FILE 21MM SZ 20

    MDR report key: 3647942 · Received February 6, 2014

    Report

    Report Number
    2523190-2014-00010
    Event Type
    Injury
    Date Received
    February 6, 2014
    Report Date
    January 29, 2014
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    EKS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE FILE BROKE IN THE ROOT OF THE TOOTH DURING USE. PATIENT WAS SENT TO SEE A SPECIALIST BECAUSE OF THE DAMAGE. ON (B)(6) 2014 CUSTOMER REPORTS DOCTOR WAS PERFORMING A ROOT CANAL WHEN THE DEVICE BROKE AND THE PART REMAINS IN THE ROOT CANAL. PATIENT IS TO SEE AN ENDODONTIST. ANTIBIOTICS WERE PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78126 SCHEIN K-FILE 21MM SZ 20 M50 - ENDODONTICS EKS INTEGRA YORK, PA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR