BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE

    MDR report key: 1201586 · Received October 17, 2008

    Report

    Report Number
    1721411-2008-00098
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    June 26, 2008
    Report Date
    July 3, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    DZE
    PMA / PMN Number
    K013867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE IMPLANTS INVOLVED MALFUNCTIONED. HOWEVER, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY PER 21 CFR PART 803, DUE TO THE FACT THAT INTERVENTION WAS REQUIRED AND BECAUSE OF THE POSSIBILITY THAT PERMANENT IMPAIRMENT OF BODY FUNCTION RESULTED. THE DEVICE WAS RETURNED, EVALUATED FOR DIMENSIONAL PROPERTIES, AND FOUND TO BE IN SPEC.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO IMPLANTS PRESSED ON THE ID NERVE, CAUSING NUMBNESS AND PAIN. AS A RESULT, THE IMPLANTS WERE REMOVED SEVEN WEEKS AFTER PLACEMENT. F/U WITH THE COMPLAINANT INDICATES THAT THE SYMPTOMS IMPROVED AND THE PAIN RESOLVED, THOUGH SOME NUMBNESS WAS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIVE DZE DENTSPLY TULSA NA 104971171650

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention