BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    78 ROOT TOP ELEV.

    MDR report key: 3855709 · Received April 21, 2014

    Report

    Report Number
    2523190-2014-00019
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    March 27, 2014
    Manufacturer
    INTEGRA YORK, PA INC
    Product Code
    EMJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAD NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTS BROKEN TIP. NO FURTHER INFORMATION AVAILABLE, DOCTOR NOT RESPONDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241976 78 ROOT TOP ELEV. M51- GENERAL DENTISTRY EMJ INTEGRA YORK, PA INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1