BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 4862966 · Received June 1, 2015

    Report

    Report Number
    3008272529-2015-00015
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    THE DOCTOR SAID THAT THE TRAJECTORY OF THE SLEEVE LOOKED TO LINGUAL ON THE GUIDE, BUT HE INITIALLY THOUGHT THAT IT MIGHT HAVE JUST BEEN HIS PERCEPTION. HE WENT BACK AND EVALUATED THE TRAJECTORY ON THE PLANNING SOFTWARE TO MAKE SURE, AND HE SAID IT LOOKED GOOD AND PROCEEDED WITH THE SURGERY. HOWEVER, AFTER USING THE INITIAL DRILL, HE FELT THAT THE TRAJECTORY WAS MUCH TOO LINGUAL. THE DOCTOR REMOVED THE GUIDE AND THEN PUT UP A MEASURING POST TO SEE WHERE THE TRAJECTORY WAS AND HE DETERMINED IT WAS COMPLETELY OFF. THE DOCTOR OPENED UP A FLAP AND NOTICED THAT THE TRAJECTORY WAS MORE LINGUAL THAN HE HAD ORIGINALLY PLANNED. HE HAD TO BONE GRAFT AND FINISH THE SURGERY FREEHANDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354128 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention