BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TILOS PATIENT MEDIUM PACK KIT

    MDR report key: 7131675 · Received December 19, 2017

    Report

    Report Number
    1718912-2017-00038
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    September 3, 2014
    Report Date
    December 19, 2017
    Manufacturer
    ULTRADENT PRODUCTS INC.
    Product Code
    EKS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    DENTAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RETURNED FOR EVALUATION AND THE OUTCOME OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION COULD BE OBTAINED. REFILING DUE TO ORIGINAL REPORT NOT BEING SUCCESSFULLY UPLOADED TO DATA BASE

    Description of Event or Problem · 1

    DENTIST WAS WORKING ON TOOTH WHEN THE FILE BROKE WHERE THE TWIST OF THE FILE STARTS. DENTIST TRIED TO RETRIEVE BUT WAS UNSUCCESSFUL. THE PATIENT WAS REFERED TO AN ENDODONTIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907003 TILOS PATIENT MEDIUM PACK KIT ENDO FILE EKS ULTRADENT PRODUCTS INC. B94SP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other