BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMAGE GUIDED IMPLANTOLOGY SYSTEM -- IGI

    MDR report key: 1040659 · Received May 8, 2008

    Report

    Report Number
    3002725845-2008-00001
    Event Type
    Other
    Date Received
    May 8, 2008
    Date of Event
    November 24, 2004
    Manufacturer
    IMAGE NAVIGATION LTD.
    Product Code
    HAW
    PMA / PMN Number
    023424
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    INFO ABOUT THIS EVENT REPORTED TO MFR MORE THAN THREE YEARS AFTER INCIDENT. USER REFUSED TO PROVIDE ADDITIONAL INFO OR DEVICE TO MFR.

    Description of Event or Problem · 1

    REPORT OF PARESTHESIA OF LOWER LIP FOLLOWING DENTAL IMPLANT SURGERY. UNK WHETHER CONDITION IS TEMPORARY OR PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMAGE GUIDED IMPLANTOLOGY SYSTEM -- IGI IGI HAW IMAGE NAVIGATION LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1