BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 5061169 · Received September 1, 2015

    Report

    Report Number
    3008272529-2015-00017
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    January 14, 2015
    Report Date
    January 15, 2015
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    DR. (B)(6) ADMINISTERED LOCAL ANESTHESIA. HE PERFORMED A TISSUE FLAP TO SEAT THE GUIDE. AFTER USING THE GUIDE TO ESTABLISH THE PILOT DRILL, DOCTOR CONCLUDED THAT THE TRAJECTORY FOR IMPLANT SITES #18 AND #19 WERE INCORRECT. IMPLANT SITE #18 WAS ABOUT 5MM CRESTAL AND IMPLANT SITE #19 WAS PLACED TOO BUCCAL. SURGERY WITH THE GUIDE WAS CEASED AND DOCTOR PROCEEDED TO BONE GRAFT THE AREA AND FINISH WITH SUTURES. DOCTOR SUSPECTS THAT THE INCORRECT TREATMENT PLAN WAS USED TO FABRICATE THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579714 ANATOMAGE GUIDE SURGICAL GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention