BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCLUSIVE MINI-IMPLANT

    MDR report key: 3263611 · Received March 5, 2013

    Report

    Report Number
    3002195199-2013-00004
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    October 15, 2012
    Report Date
    March 5, 2013
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Product Code
    DZE
    PMA / PMN Number
    K100932
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOR THIS DEVICE HAS NOT YET BEEN COMPLETED. AN UPDATE WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. CATALOG # 2215, LOT # 6000961.

    Description of Event or Problem · 1

    THE DENTIST REPORTED THAT 3 IMPLANTS WERE MOBILE AND REMOVED DUE TO PAIN AND SORENESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94898 INCLUSIVE MINI-IMPLANT DENTAL IMPLANT, PRODUCT CODE: DZE DZE PRISMATIK DENTALCRAFT, INC. 6000960

    Patients

    Seq Age Sex Outcome Treatment
    1