BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAYFUSE FUSION SYSTEM

    MDR report key: 3068480 · Received February 14, 2006

    Report

    Report Number
    2030833-2006-00013
    Event Type
    Other
    Date Received
    February 14, 2006
    Date of Event
    October 11, 2006
    Report Date
    November 27, 2006
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K022726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL#: STA-P3; CATALOG#: STA-P3; LOT#: K08609; EXP DATE: 01/01/2011.

    Description of Event or Problem · 1

    DURING ROUTINE F/U, SURGEON NOTED THAT PROXIMAL AND DISTAL DEVICES HAD BECOME DISENGAGED. SURGEON ELECTED TO REVISE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAYFUSE FUSION SYSTEM INTERPHALAGEAL FUSION DEVICE HWC NEXA ORTHOPEDICS, INC. STA-D4 K08599

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other