BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRAPHIC CASE

    MDR report key: 2822633 · Received November 7, 2012

    Report

    Report Number
    2520274-2012-02982
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 26, 2012
    Product Code
    NKB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    SYNTHES CONSULTANT REPORTED: MATRIX NEURO SET LID HAS PEELING GRAPHICS. THE PEELED GRAPHICS ARE REPORTEDLY GETTING INTO THE PLATES AND SCREWS WHEN WASHED. THE GRAPHIC CASE WAS ADDED TO THIS COMPLAINT AS A REPORTABLE EVENT DUE TO; GRAPHICS REPRESENT THE POTENTIAL FOR UNRETRIEVED DEVICE FRAGMENTS OF NON-IMPLANT GRADE MATERIAL. THIS IS 3 OF 3 REPORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GRAPHIC CASE NKB

    Patients

    Seq Age Sex Outcome Treatment
    1