BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOSTON KERATOPROSTHESIS

    MDR report key: 3038263 · Received April 2, 2013

    Report

    Report Number
    1222945-2013-00003
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 15, 2013
    Manufacturer
    MASSACHUSETTS EYE AND EAR INFIRMARY
    Product Code
    HQM
    PMA / PMN Number
    K915062
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE BROKEN BACK PLATE WAS CONFIRMED ON THE EXAMINATION OF THE RETURNED PRODUCT. THE INSTRUCTIONS FOR ASSEMBLY OF THE KPRO CALL FOR PUSHING THE LOCKING RING DOWN INTO THE GROOVE WITH THE ASSEMBLY PIN AT 90 DEGREES FROM THE FRONT PLATE. THE BREAKAGE CAN OCCUR IF THE TOOL IS NOT PERFECTLY PERPENDICULAR AND IT HITS THE BACK PLATE. THE INSTRUCTIONS CLEARLY INDICATE, THAT THE GRAFT-PROSTHETIC COMBINATION AFTER THE INSPECTION UNDER THE MICROSCOPE HAS TO BE REMOVED FROM THE ADHESIVE AND STORED IN THE EYE BANK SOLUTION WHILE THE PT'S EYE IS PREPARED. THE ASSEMBLY WAS PERFORMED BY AN INEXPERIENCED ASSISTANT, BUT THE PT'S CORNEA WAS ALREADY REMOVED AND THE DOCTOR DECIDED TO SUTURE THE GRAFT-PROSTHETIC COMBINATION INTO THE PT'S EYE AS A TEMPORARY MEASURE.

    Description of Event or Problem · 1

    BOSTON KERATOPROSTHESIS WAS ASSEMBLED BY THE CORNEA FELLOW IN TRAINING WHILE THE ATTENDING DOCTOR REMOVED THE PT'S CORNEA. WHILE ATTEMPTING TO USE THE LOCKING PIN TO LOCK THE TITANIUM RING OVER THE BACK PLATE, THE TOOL WAS IMPROPERLY POSITIONED OVER THE RING. WHEN DOWNWARD PRESSURE WAS APPLIED, THE TOOL WAS NOT PERFECTLY PERPENDICULAR AND CAUSED A FRACTURE OF THE BACK PLATE. SINCE THE HOST CORNEA WAS ALREADY REMOVED, THE DOCTOR DECIDED TO SUTURE THE GRAFT - PROSTHETIC COMBINATION WITHOUT BACK PLATE AS A TEMPORARY MEASURE. THE NEXT DAY, THE DOCTOR CONTACTED BOSTON KERATOPROSTHESIS AND FOLLOWING THE ADVICE OF BOSTON KPRO, HE SUCCESSFULLY COMPLETED THE SURGERY WITH A NEW BACK PLATE AND TITANIUM RING 2 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134270 BOSTON KERATOPROSTHESIS KERATOPROSTHESIS HQM MASSACHUSETTS EYE AND EAR INFIRMARY TYPE I BP091812; LR-082212

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR