BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE

    MDR report key: 1201857 · Received October 15, 2008

    Report

    Report Number
    1721411-2008-00099
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    July 31, 2008
    Report Date
    September 15, 2008
    Manufacturer
    DENTSPLY TULSA
    Product Code
    DZE
    PMA / PMN Number
    K013867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THAT THE IMPLANT 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 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

    IT WAS REPORTED THAT A XIVE IMPLANT CAUSED PARTIAL PARAESTHESIA. AS A RESULT, THE IMPLANT WAS REMOVED TWO WEEKS AFTER PLACEMENT. THE PATIENT HAD NOT REGAINED FEELING AS OF THE LAST COMMUNICATION WITH THE DOCTOR, WHO INDICATED THAT THE SYMPTOMS COULD TAKE 4-6 MONTHS TO RECOVER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention