BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRIALIT PLUS IMPLANT

    MDR report key: 3030612 · Received March 21, 2013

    Report

    Report Number
    9681851-2013-00003
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    December 28, 2012
    Report Date
    January 25, 2013
    Manufacturer
    DENTSPLY IMPLANTS MANUFACTURING GMBH
    Product Code
    DZE
    PMA / PMN Number
    K031674
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE INVESTIGATION, IT WAS FOUND THAT THE IMPLANT USED WAS A TRAINING IMPLANT INTENDED FOR HANDS-ON TRAINING AND THUS NOT INTENDED FOR THE USE IN THE HUMAN ORAL CAVITY. THESE TYPES OF IMPLANTS ARE DESIGNED COMPARABLY TO THE ORIGINAL ONES, BUT NOT TREATED IN THE SAME WAY; THIS APPLIES FOR SHIPPING IT IN A NON-STERILE CONDITION IN PARTICULAR. THE LABELING CLEARLY INDICATES THAT THESE TRAINING IMPLANTS ARE NOT FOR HUMAN USE AND THE COMPLETE IMPLANT BODY IS COLOR-CODED IN MAGENTA (I.E. CORRESPONDING COLOR FOR PRODUCTS OF 5.5 MM DIAMETER) WHICH IS ACHIEVED BY ANODIC OXIDATION; WHEREAS IMPLANTS FOR USE IN THE PATIENT'S MOUTH ARE OF SILVERISH TITANIUM-COLOR. IN THIS CASE, IT CAN BE CONCLUDED THAT THE IMPLANT FAILURE WAS CAUSED BY THE SELECTION OF AN IMPLANT TYPE THAT IS CONTRAINDICATED FOR CLINICAL APPLICATION. SINCE THE LABELING WAS SUFFICIENTLY INDICATING THIS BY THE TERM "NOT FOR HUMAN USE" A PRODUCT RELATED PROBLEM CAN BE EXCLUDED. HOWEVER, BECAUSE MEDICAL INTERVENTION WAS NECESSARY IN THIS EVENT, IT IS REPORTABLE PER 21 CFR PART 803.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A FRIALIT IMPLANT FAILED TO OSSEOINTEGRATE. ON (B)(6) 2012 THE DENTIST DECIDED TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117637 FRIALIT PLUS IMPLANT DZE DENTSPLY IMPLANTS MANUFACTURING GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention