BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS

    MDR report key: 2161231 · Received July 8, 2011

    Report

    Report Number
    9681851-2011-00015
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    December 17, 2010
    Report Date
    June 16, 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

    THEREFORE, BECAUSE MEDICAL INTERVENTION WAS NECESSARY TO PRECLUDE A SERIOUS INJURY, 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 AN IMPLANT WAS EXTRACTED APPROXIMATELY THREE MONTHS AFTER PLACEMENT DUE TO A TITANIUM INTOLERANCE WHICH WAS CONFIRMED BY A TITANIUM STIMULATION TEST. THERE IS NO INFORMATION AVAILABLE ABOUT THE SYMPTOMS THE PATIENT EXPERIENCED WHICH RESULTED IN THIS TEST BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIVE S PLUS DZE FRIADENT GMBH B100006185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention