BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALPHASPHERE ORBITAL IMPLANT

    MDR report key: 2115161 · Received May 26, 2011

    Report

    Report Number
    3005344923-2011-00001
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    April 8, 2011
    Report Date
    May 25, 2011
    Manufacturer
    ADDITION TECHNOLOGY
    Product Code
    HPZ
    PMA / PMN Number
    K053298
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR WHY THIS UNIT WAS REJECTED BY THE PT. TYPICALLY, ALPHASPHERE UNITS BIOINTEGRATE WITH THE PT'S MUSCLES WITHOUT ISSUE. THIS IS THE FIRST COMPLAINT OF THIS TYPE AND SINCE THERE IS ONLY ONE DATA POINT AND NO UNIT TO EXAMINE, NO CONCLUSIONS CAN RELIABLE BE DRAWN.

    Description of Event or Problem · 1

    PT PRESENTED FOR F/U ONE MONTH SUBSEQUENT TO THE INSERTION OF AN ORBITAL IMPLANT. THE ORBITAL IMPLANT WAS INSERTED AFTER ENUCLEATION OF THE EYE FOR CHOROIDAL MELANOMA. THE PT WAS FOUND TO HAVE CONJUNCTIVAL DEHISCENCE OVER THE IMPLANT. THE PT WAS INITIALLY RETURNED TO THE OPERATING ROOM FOR CONJUNCTIVAL REPAIR INSTEAD OF IMPLANT EXCHANGE. THE WOUND WAS EXPLORED. THE MESH CONNECTING THE TWO HEMISPHERES OF THE DEVICE WAS FOUND TO BE VERY FRIABLE AND THE MUSCLES WERE NO LONGER ATTACHED TO THE IMPLANT DESPITE ATTEMPTS MADE DURING THE PRIMARY PROCEDURE TO ENSURE SUTURING TO THE MESH. THE CAPSULE AROUND THE IMPLANT WAS SUBMITTED FOR PATHOLOGY AND REVEALED FOREIGN BODY GIANT CELL REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALPHASPHERE ORBITAL IMPLANT 886.3320 - HPZ HPZ ADDITION TECHNOLOGY AS-22 AS-134-10B

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention POSSIBLE RADIATION TREATMENT.