BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS

    MDR report key: 2161230 · Received July 8, 2011

    Report

    Report Number
    9681851-2011-00014
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K073075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS TESTED VIA THE EAV (BIOELECTRIC-FUNCTIONAL ANALYSIS) METHOD, WHICH REVEALED CP TITANIUM INTOLERANCE. HOWEVER, THIS TEST PROCEDURE IS BASED ON TRADITIONAL (B)(4) MEDICAL CONCEPTS, WHICH ARE NOT IN ACCORDANCE WITH SCIENTIFIC MEDICINE. IT COULD BE SUSPECTED THAT THE SYMPTOMS DESCRIBED MAY HAVE OCCURRED DUE TO OTHER REASONS, SUCH AS ANESTHETICS. WHILE IT IS UNKNOWN IF THE DENTAL IMPLANT USED IN THIS CASE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS, IT IS POSSIBLE AS ALLERGIC REACTIONS TO DENTAL MATERIALS ARE KNOWN AND REPORTED, WITH MEDICAL CONSEQUENCES BEING DEPENDENT UPON THE SEVERITY OF THE INDIVIDUAL ALLERGIC RESPONSE AND SUBSEQUENT EXPOSURE TO THE SAME MATERIAL. THEREFORE, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803. EVALUATION OF THE IMPLANT'S SURFACE PROPERTIES DID NOT SHOW ANY DEVIATIONS.

    Description of Event or Problem · 1

    IN THIS EVENT, IT WAS REPORTED THAT A XIVE PLUS IMPLANT WAS REMOVED ONE WEEK AFTER PLACEMENT DUE TO SYMPTOMS THE PATIENT WAS EXPERIENCING. THE REPORTED SYMPTOMS INCLUDE GENERAL MALAISE, INSOMNIA, RESTLESSNESS, AND A BURNING SENSATION IN THE SURGICAL FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIVE S PLUS DZE FRIADENT GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention