BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIDENTIFIED ENDODONTIC FILE

    MDR report key: 432640 · Received December 12, 2002

    Report

    Report Number
    2016150-2002-00002
    Event Type
    Injury
    Date Received
    December 12, 2002
    Date of Event
    June 7, 2001
    Report Date
    October 23, 2002
    Manufacturer
    SYBRON ENDO/ANALYTIC, A DIVISION OF ORMCO CORP
    Product Code
    EKS
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    IN 2001, A PATIENT UNDERWENT ROOT CANAL TREATMENT. DURING THE PROCEDURE A SMALL PIECE, APPROXIMATELY 8 MM IN SIZE, OF AN UNIDENTIFIED ENDODONTIC FILE BROKE OFF AND BECAME IMBEDDED IN THE PATIENT'S TOOTH. THE PATIENT ALLEGEDLY REQUIRED ORAL SURGERY TO EXTRACT THE PIECE OF THE FILE FROM THE TOOTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNIDENTIFIED ENDODONTIC FILE ENDODONTIC FILE EKS SYBRON ENDO/ANALYTIC, A DIVISION OF ORMCO CORP UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other