BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCU-GUARD

    MDR report key: 495739 · Received November 14, 2003

    Report

    Report Number
    2183620-2003-00041
    Event Type
    Injury
    Date Received
    November 14, 2003
    Report Date
    October 15, 2003
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    MTZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENUCLEATION PROCEDURE (DATE UNK) FOLLOWED BY IMPLANTATION OF HYDRAOXYAPATITE ORBITAL PROSTHESIS IMPLANT ALONG WITH OCU-GUARD ORBITAL IMPLANT WRAP. AT APPROXIMATELY 8 MONTHS POST-IMPLANT, PT PRESENTED WITH EXPOSURE, REQUIRING REMOVAL OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCU-GUARD ORBITAL IMPLANT WRAP MTZ SYNOVIS SURGICAL INNOVATIONS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention HYDROXYAPATITE ORBITAL PROSTHESIS.