BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE

    MDR report key: 2201319 · Received August 3, 2011

    Report

    Report Number
    3005477956-2011-00001
    Event Type
    Malfunction
    Date Received
    August 3, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 4, 2011
    Manufacturer
    PRIZMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THREE OUT OF SIX 3.0 MM X 10 MM MINI IMPLANTS WERE REPORTED TO HAVE LOST STABILITY WITHIN A MONTH OF PLACEMENT. THE CAUSE WAS MOST LIKELY DUE TO OVERLOADING BY THE PROVISIONAL DENTURE. DOCTOR PATEL PLACED WIDER, 3.25 MM TRADITIONAL IMPLANTS, ONCE THE 3.0 MM IMPLANTS WERE REMOVED. THE REMAINING THREE IMPLANTS APPEAR TO BE STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCLUSIVE MINI IMPLANT DZE PRIZMATIK DENTALCRAFT, INC. NA 6000793

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention