BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAYFUSE

    MDR report key: 1017126 · Received March 18, 2008

    Report

    Report Number
    2030833-2008-00003
    Event Type
    Other
    Date Received
    March 18, 2008
    Date of Event
    December 12, 2007
    Report Date
    March 19, 2008
    Manufacturer
    TORNIER INC.
    Product Code
    HWC
    PMA / PMN Number
    K022726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A STAYFUSE DEVICE (MODEL NUMBER NOT AVAILABLE) WAS IMPLANTED IN THE RIGHT SECOND METATARSAL PHALANGEAL JOINT BY D.P.M. IN 2007, AT HOSPITAL. SUBSEQUENTLY, IT BECAME DISENGAGED AND THE FUSION BECAME DISPLACED. FROM THE OPERATIVE REPORT FOR 2007, BY NE D.P.M.: "....THE PREVIOUS STAYFUSE DEVICE WAS COMPLETELY ENGAGED. IT WAS FIRST CHECKED AND THEN TRIED TO RE-ENGAGE.....THE DECISION WAS TO REMOVE THE STAYFUSE DEVICE AND PLACE A BRAND NEW STAYFUSE DEVICE AND SEE IF THAT WOULD FUNCTION PROPERLY........UPON GENTLE PULLING OF THE DISTAL END OF THE TOE, THE STAYFUSE DEVICE AGAIN CAME APART. THE DECISION WAS MADE AT THIS TIME TO REMOVE THE STAYFUSE DEVICE......AND A .062" K-WIRE WAS RETROGRADED OUT THE DISTAL ASPECT OF THE SECOND TOE AND BACK INTO THE BASE OF THE PROXIMAL PHALANX."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAYFUSE INTRAMEDULLARY FUSION DEVICE HWC TORNIER INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R