BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 12037291 · Received June 21, 2021

    Report

    Report Number
    3008272529-2021-00015
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    April 21, 2021
    Report Date
    June 18, 2021
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON OUR INVESTIGATION, WE CAN CONCLUDE THAT THE TRAJECTORY OF THE RETURNED GUIDE ALIGNS WITH THE DOCTOR'S APPROVED FINAL PLAN. ADDITIONALLY, ALL PRODUCTION PROCESSES WERE FOUND TO HAVE BEEN PROPERLY FOLLOWED. THE TRAJECTORY DEVIATION MAY HAVE OCCURRED DURING FREE-HANDING PROCEDURES, OR MAY HAVE BEEN CAUSED BY COMPLEX CLINICAL ASPECTS OUTSIDE THE SCOPE OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    AFTER USING THE GUIDE TO PLACE IMPLANT #19, THE IMPLANT WAS ~0.5 MM FROM THE ROOT OF TOOTH #20 . THE DOCTOR REMOVED THE IMPLANT AND GRAFTED THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934161 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention