BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 11795191 · Received May 8, 2021

    Report

    Report Number
    3008272529-2021-00010
    Event Type
    Injury
    Date Received
    May 8, 2021
    Date of Event
    January 10, 2020
    Report Date
    May 7, 2021
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 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, AND MAY HAVE BEEN DUE TO COMPLEX CLINICAL ASPECTS OUTSIDE THE SCOPE OF THIS INVESTIGATION.

    Description of Event or Problem · 1

    THE GUIDE WAS USED FOR IMPLANT SURGERY. AFTER PERFORMING THE INITIAL OSTEOTOMY, THE DOCTOR USED DIRECTIONAL PINS TO CONFIRM THE TRAJECTORY AND FELT THAT THE AXIS WAS NOT SIGNIFICANTLY OFF. HOWEVER, AFTER PLACING THE IMPLANT AND TAKING A POST-OP SCAN, THE DOCTOR OBSERVED THAT THE IMPLANT WAS VERY DISTAL AND CLOSE TO THE ROOT OF MOLAR #2. HE ULTIMATELY REMOVED THE IMPLANT AND GRAFTED THE AREA, AND WILL ORDER A NEW GUIDE AND REATTEMPT SURGERY AT A LATER DATE. THE DOCTOR ALSO ORDERED A MANDIBULAR GUIDE FOR TWO IMPLANT SITES, BOTH OF WHICH WERE PLACED SUCCESSFULLY USING THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691461 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention