BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON KERATOPROSTHESIS

    MDR report key: 2971543 · Received February 1, 2013

    Report

    Report Number
    1222945-2013-00002
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    December 18, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MASSACHUSETTS EYE AND EAR INFIRMARY
    Product Code
    HQM
    PMA / PMN Number
    K915062
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN BACK PLATE WAS CONFIRMED ON EXAMINATION OF THE RETURNED PRODUCT. PMMA CAN FRACTURE WHEN STRUCK DIRECTLY. THE INSTRUCTIONS FOR THE ASSEMBLY CALL FOR PUSHING THE LOCKING RING ONTO THE STEM OF THE FRONT PLATE TO SECURE THE BACK PLATE. IF THE BACK PLATE IS STRUCK DIRECTLY BY THE ASSEMBLY TOOL, IT MAY FRACTURE FROM THE FORCE OF THE HIT. THERE WAS NO PATIENT INVOLVEMENT AS THE ASSEMBLY IS DONE PRIOR TO ANY PATIENT CONTACT WITH THE DEVICE. IT APPEARS THAT DURING SHIPMENT OR SUBSEQUENT HANDLING, THE BACK PLATE SLIPPED ONTO THE STEM OF THE FRONT PLATE. THE LOCKING RING WAS NOT ENGAGED, SO THE DEVICE WAS NOT TRULY ASSEMBLED. A REVIEW OF THE PACKAGING AND ASSEMBLY FOR BOSTON KERATOPROSTHESIS WAS REVIEWED AND THE INSPECTIONS OF THE COMPONENTS SHOWED NO INDICATION OF DAMAGE OR CHIPS. THE PACKAGING PROCESS REQUIRES TWO SEPARATE MICROSCOPIC EXAMINATIONS OF EACH COMPONENT OR DEBRIS OR DAMAGE.

    Description of Event or Problem · 1

    BACK PLATE FRACTURED UPON PLACEMENT ONTO ONE FRONT PLATE-CORNEA/DONOR COMPLEX. NO PATIENT INVOLVEMENT. UPON OPENING PACKAGE AND INSPECTING THE BOSTON KERATOPROSTHESIS, FRONT PLATE AND BACK PLATE WERE ASSEMBLED- WHEN INSPECTING FRONT PLATE, SMALL CHIP NOTED IN OPTIC WITH CHIP PIECE MISSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45368 BOSTON KERATOPROSTHESIS KERATOPROSTHESIS HQM MASSACHUSETTS EYE AND EAR INFIRMARY TYPE I

    Patients

    Seq Age Sex Outcome Treatment
    1