BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITEK INC

    MDR report key: 1027037 · Received April 4, 2008

    Report

    Report Number
    MW5006181
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 4, 2008
    Manufacturer
    VITEK, INC (NO LONGER IN BUSINESS)
    Product Code
    LZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1984 PT HAD VITEK IPIS INSTALLED BUT THEY FAILED AFTER 6 MONTHS. IN 1986 VKIIS WERE INSTALLED ON BOTH SIDES OF THE JAW. PT HAD THESE IN FOR 20 YRS WITHOUT ANY KNOWN PROBLEMS. PT WAS NEVER NOTIFIED ABOUT THE VITEK RECALL AND JUST RECENTLY LEARNED ABOUT IT BECAUSE HE'S NOW EXPERIENCING A NUMBER OF HEALTH-RELATED PROBLEMS. PT'S JAW HAS EXCESSIVE BONE LOSS DUE TO IMPLANT. X-RAYS SHOW ALL THE IMPLANT SCREWS ARE LOOSE AND A MASS GROWING ON THE RIGHT SIDE. IMPLANT ON RIGHT SIDE HAS COMPLETELY PULLED AWAY FROM JAW WITH TWO SCREWS ARE COMPLETELY OUT AND ONE IS BENT. ALL THE SCREWS ARE LOOSE ON THE LEFT SIDE AND ONE IS BROKEN. CT SCAN SHOWS LOTS OF BONE LOSS COMPARED PRIOR TO IMPLANTATION. PT HAS LIVER AND SPLEEN PROBLEMS. SINCE LAST FALL PT IS PASSING A KIDNEY STONE ABOUT EVERY 2 WEEKS. THERE IS A CYST ON RIGHT KIDNEY. PT IS EXPERIENCING ABDOMINAL PAIN AND HAS LOTS OF GI PROBLEMS. OMS IS CONCERNED ABOUT THE LACK OF BONE IN WHICH TO ANCHOR THE NEW IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITEK INC VKII AND VITEK IPI LZD VITEK, INC (NO LONGER IN BUSINESS)

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| O| R| S