BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIVE S PLUS

    MDR report key: 2833061 · Received November 5, 2012

    Report

    Report Number
    9681851-2012-00009
    Event Type
    Injury
    Date Received
    November 5, 2012
    Date of Event
    May 26, 2012
    Report Date
    October 19, 2012
    Manufacturer
    FRIADENT GMBH
    Product Code
    DZE
    PMA / PMN Number
    K073075
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THERE IS A FAST IMPROVEMENT OF THE SYMPTOMS IT CAN BE ASSUMED THAT THE PT WILL FULLY RECOVER. GENERALLY, SUCH CASES ARE NOT UNK 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 WAS RETURNED, EVALUATED FOR DIAMETER AND LENGTH MEASUREMENTS, AND FOUND TO BE IN SPECIFICATION.

    Description of Event or Problem · 1

    IN THIS EVENT IT WAS REPORTED THAT A XIVE S PLUS IMPLANT THAT WAS PLACED ON (B)(6) 2012 WAS POSITIONED TOO CLOSE TO THE MANDIBULAR NERVE, THUS THE PT COMPLAINED ABOUT PAIN AND PARAESTHESIA IN THE REGION SUPPLIED BY THE NERVE. AS A RESULT, THE IMPLANT WAS EXTRACTED SIX DAYS LATER. THE LAST F/U REVEALED AN IMPROVEMENT OF THE DISCOMFORT.

    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