BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE PREFORMED ORBITAL PLATE SMALL/LEFT

    MDR report key: 2944992 · Received February 6, 2013

    Report

    Report Number
    8030965-2013-00328
    Event Type
    Injury
    Date Received
    February 6, 2013
    Report Date
    January 11, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JEY
    PMA / PMN Number
    K080331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A PREFORMED ORBITAL FLOOR PLATE AND ONE SCREW ON THE LEFT EYE ON (B)(6) 2012. THE PATIENT WAS EXPERIENCING ENOPTHALMIA, SO THE SURGEON WANTED TO REPOSITION THE PLATE BECAUSE THE PATIENT'S EYE WAS NOT SITTING CORRECTLY. THE SURGEON ENDED UP REMOVING THE ORBITAL PLATE AND SCREW ON (B)(6) 2013 AND REPLACING IT WITH ANOTHER ORBITAL PLATE AND TWO SCREWS. THE REMOVAL PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50957 TI MATRIXMIDFACE PREFORMED ORBITAL PLATE SMALL/LEFT MATRIXMIDFACE PREFORMED ORBITAL PLATE JEY SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention