BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    X-GUIDE X-MARK PROBE TOOL

    MDR report key: 12722350 · Received October 29, 2021

    Report

    Report Number
    3011764595-2021-00001
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 29, 2021
    Manufacturer
    X-NAV TECHNOLOGIES, LLC
    Product Code
    PLV
    UDI-DI
    00817421020995
    PMA / PMN Number
    K192579
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE DOCTOR'S PROBE TOOL TIP BECAME LOOSE DURING ORAL SURGERY WHILE HE WAS REGISTERING POINTS IN THE PATIENT'S MOUTH FOR THE X-MARK PROCESS. THE DOCTOR WAS ABLE TO RETRIEVE THE TIP BEFORE IT FELL INTO THE PATIENT'S MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1615435 X-GUIDE X-MARK PROBE TOOL DENTAL SURGICAL NAVIGATION DEVICE PLV X-NAV TECHNOLOGIES, LLC P010673 2007010010 00817421020995

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown