BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 6123047 · Received November 22, 2016

    Report

    Report Number
    3008272529-2016-00035
    Event Type
    Injury
    Date Received
    November 22, 2016
    Date of Event
    October 28, 2016
    Report Date
    October 28, 2016
    Manufacturer
    ANATOMAGE
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION DID NOT SHOW ANY MALFUNCTION. THE FIT ISSUE MAY BE CAUSED BY COMBINATION OF STONE MODEL DISTORTION AND/OR UNFORESEEN CHANGE IN PATIENT'S MANDIBLE MORPHOLOGY AFTER THE PREPARATION PROCEDURES.

    Description of Event or Problem · 1

    DOCTOR EXTRACTED THE TEETH AT THE IMPLANT SITES, PERFORMED ALL THE FLAPS REQUIRED, SHAVED TOOTH #22 BY 0.4MM BUT THE GUIDE WOULD ROCK BACK AND FORTH ON BOTH SIDES OF THE ARCH. SINCE THE IMPLANTS WERE PLANNED CLOSE TO THE NERVE, THE DOCTOR DECIDED NOT TO FREEHAND THIS SURGERY AND ABORTED THE SURGERY. DOCTOR GRAFTED THE IMPLANT SITES AND CLOSED THE TISSUE FLAPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771980 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention