BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKYLOS C/X IMPLANT

    MDR report key: 2911111 · Received January 7, 2013

    Report

    Report Number
    9681851-2013-00001
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K083805
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BESIDES THE FACT THAT THE COMBINATION OF IMMEDIATE LOADING AND GRAFTING MIGHT HAVE POTENTIALLY A NEGATIVE INFLUENCE ON THE IMPLANT SUCCESS; THE CHOSEN CONCEPT SEEMS NOT TO BE THE MAIN CAUSE FOR THE FAILURE, SINCE IT TURNED OUT 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. THE INVESTIGATION OF THIS SPECIFIC IMPLANT SHOWED THAT THE LABEL WAS FLAWLESS. HOWEVER, IT REMAINS UNCLEAR HOW THE DENTIST RECEIVED THIS PRODUCT, SINCE IT SEEMS IT WAS NOT SHIPPED BY THE DEALER. 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. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH RESULTS ARE NOT AVAILABLE AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT AN ANKYLOS C/X IMPLANT, WHICH WAS PLACED ON (B)(6) 2012, FAILED TO OSSEOINTEGRATE. THE SITE WAS GRAFTED SIMULTANEOUSLY AND THE IMPLANT WAS RESTORED IMMEDIATELY BY UTILIZING A TEMPORARY RESTORATION. ON (B)(6) 2012, THE DENTIST DISCOVERED THAT THE IMPLANT DID NOT OSSEOINTEGRATE SUCCESSFULLY AND HE REMOVED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8070 ANKYLOS C/X IMPLANT DZE FRIADENT GMBH 0020043371

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention TEMP ABUTMENT, PROVISIONAL RESTORATION