BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANATOMAGE GUIDE

    MDR report key: 5130856 · Received September 23, 2015

    Report

    Report Number
    3008272529-2015-00019
    Event Type
    Injury
    Date Received
    September 23, 2015
    Report Date
    January 12, 2015
    Manufacturer
    ANATOMAGE INC.
    Product Code
    NDP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED THAT IMPLANT #10 WAS TOO PALATAL AND IT PERFORATED THE PALATAL PLATE. THE DR. HAD TO GRAFT AND CLOSE THE PT. THE INITIAL REPORTER STATED THAT THE GUIDE DID NOT HAVE ANY FIT ISSUES. SEE SCANNED PAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629403 ANATOMAGE GUIDE NDP ANATOMAGE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention