BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 11803524 · Received May 10, 2021

    Report

    Report Number
    3008272529-2021-00011
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 10, 2020
    Report Date
    May 10, 2021
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. AS SUCH, THE CAUSE OF THE TRAJECTORY DEVIATION COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    THE GUIDE WAS USED FOR IMPLANT SURGERY. FOR SITE #9, THE DOCTOR USED A TISSUE PUNCH, THEN COMPLETED THE DRILLING SEQUENCE. WHEN SHE WENT TO PLACE THE IMPLANT, SHE REALIZED THAT SHE COULD NOT FIND THE OSTEOTOMY THROUGH THE TISSUE PUNCH. SHE THEN LAID A TISSUE FLAP, AND FOUND THAT THE BUCCAL BONE WAS COMPLETELY MISSING. THE SITE WAS THEN GRAFTED, AND THE DOCTOR PLANS ON ATTEMPTING THE SURGERY AFTER THE PATIENT HAS HEALED. ALL OTHER IMPLANTS (#6, 8, AND 11), WERE PLACED SUCCESSFULLY USING THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695929 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention