BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS

    MDR report key: 2911110 · Received January 7, 2013

    Report

    Report Number
    9681851-2012-00013
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 17, 2012
    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

    GENERALLY, SUCH CASES ARE NOT UNKNOWN IN IMPLANTOLOGY AND ARE USUALLY CAUSED BY AN INSUFFICIENT PLANNING OF THE IMPLANTATION. WHILE THERE IS NO INDICATION THAT THE IMPLANT INVOLVED MALFUNCTIONED, DUE TO THE FACT THAT MEDICAL INTERVENTION WAS REQUIRED, THIS EVENT MEETS THE CRITERIA FOR REPORTABILITY 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 A XIVE S PLUS IMPLANT THAT WAS INTENDED FOR TRANSGINGIVAL HEALING WAS PLACED ON (B)(6) 2012, WAS POSITIONED TOO CLOSE TO THE MANDIBULAR NERVE THUS A COMPRESSION OF THE NERVE OCCURRED; THE PATIENT RETURNED 5 DAYS LATER COMPLAINING ABOUT SEVERE PAIN. TO AVOID ANY FURTHER DAMAGE OF THE NERVE THE IMPLANT WAS REMOVED. THE DENTIST REPORTED THAT THE FOLLOW-UP VISIT ON (B)(6) 2012, SHOWED AN IMPROVEMENT OF THE SITUATION, ALTHOUGH A SLIGHT PARAESTHESIA WAS STILL DETECTABLE. SINCE THE PATIENT IS RECOVERING FAST, IT SEEMS VERY LIKELY THAT THEY WILL REGAIN THE COMPLETE NERVE SENSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6483 XIVE S PLUS DZE FRIADENT GMBH B120000749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention