BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM

    MDR report key: 2627503 · Received October 22, 2009

    Report

    Report Number
    9610667-2009-00024
    Event Type
    Malfunction
    Date Received
    October 22, 2009
    Date of Event
    September 24, 2009
    Report Date
    October 22, 2009
    Manufacturer
    TORNIER INC.
    Product Code
    NDF
    PMA / PMN Number
    022726
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT IS REPORTED THAT A STAYFUSE TOE JOINT PROSTHESIS DEVICE BECAME DISCONNECTED ABOUT SIX WEEKS POST IMPLANTATION AND REQUIRED A REPLACEMENT UNIT. DATE OF INITIAL IMPLANT HAS NOT YET BEEN PROVIDED. RADIOGRAPHS REQUESTED HAVE NOT YET BEEN PROVIDED. EXPLANTED DEVICE HAS BEEN RECOVERED FOR EXAMINATION. THE EXPLANTED FAILED DEVICE IS A MATED COMPONENT PAIR: STA-P4, LOT K10660, EXPIRY MARCH 2013; STA-D7, LOT K10621, EXPIRY FEBRUARY 2013. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORNIER STAYFUSE GREAT TOE INTERPHALANGEAL IM SCREW, FIXATION, BONE NDF TORNIER INC. K10660; K10621

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization