BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIO-EYE

    MDR report key: 1066047 · Received June 25, 2008

    Report

    Report Number
    2027377-2008-00001
    Event Type
    Injury
    Date Received
    June 25, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 23, 2008
    Manufacturer
    INTEGRATED ORBITAL IMPLANTS, INC.
    Product Code
    HPZ
    PMA / PMN Number
    K982562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN OFF SECTION OF THE IMPLANT AS WELL AS THE THREADED SLEEVE AND PEG WERE RETURNED FOR EXAMINATION. EVALUATION OF THE RETURNED COMPONENTS INDICATED THAT THE SLEEVE WAS PLACED ASYMMETRICALLY WITHIN THE ORBITAL IMPLANT. THIS WOULD HAVE RESULTED IN UNBALANCED RADIAL FORCES AND WAS LIKELY CONTRIBUTORY TO THE FAILURE OF THE DEVICE. SUBSEQUENT CONVERSATION WITH THE PHYSICIAN INDICATES THAT THE EXPLANTED DEVICE WAS FOUND TO BE DEVOID OF VASCULARIZATION - A CONDITION NOT CONSISTENT WITH THE REQUIREMENT FOR FULL VASCULARIZATION THAT WOULD HAVE BEEN THE CASE 10 YEARS AGO WHEN THE THREADED SLEEVE WAS INSERTED INTO THE ORBITAL IMPLANT. IN ADDITION, IT WAS NOTED THAT CULTURE OF THE DISCHARGE INDICATED A MRSA INFECTION. CONSULTATION WITH THE MEDICAL DIRECTOR INDICATES THAT A LONG-SEATED INFECTION MAY BE RESPONSIBLE FOR DEVASCULARIZATION OF THE IMPLANT. IT IS UNKNOWN IF THE PT HAD A LONG-TERM INFECTION OR IF THE TREATING SURGEON'S HYPOTHESIS REGARDING THE PT'S HEAVY SMOKING WERE CAUSAL IN THE DEVASCULARIZATION. IT IS HYPOTHESIZED THAT THE DEVASCULARIZATION MAY HAVE EFFECTIVELY WEAKENED THE ORBITAL IMPLANT WHICH WAS UNDER STRESS FROM THE MIS-PLACED SLEEVE, ULTIMATELY CAUSING THE IMPLANT TO FRACTURE.

    Description of Event or Problem · 1

    THE REPORT INDICATED THAT PART OF THE ORBITAL IMPLANT, SLEEVE, AND PEG HAD BROKEN INTO PIECES AND THERE WAS CONJUNCTIVAL BREAKDOWN. THE REPORT ADDITIONALLY DISCLOSED THAT CULTURE OF THE PT INDICATED A MRSA INFECTION AND THAT THE IMPLANT HAD BEEN SURGICALLY REMOVED. THE IMPLANT WAS EXAMINED AND FOUND TO HAVE NO VASCULARIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIO-EYE INTEGRATED ORBITAL IMPLANT HPZ INTEGRATED ORBITAL IMPLANTS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention