BEUDAMED
    FDA Adverse Event Other Summary report: N

    STAYFUSE

    MDR report key: 1013314 · Received March 14, 2008

    Report

    Report Number
    2030833-2008-00002
    Event Type
    Other
    Date Received
    March 14, 2008
    Date of Event
    October 12, 2007
    Report Date
    February 24, 2008
    Manufacturer
    NEXA ORTHOPEDICS, INC.
    Product Code
    HWC
    PMA / PMN Number
    K022726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT DESCRIBED AN EXPLANT OF A STAYFUSE DEVICE AND AN IMPLANT OF A SCREW TO REPLACE IT. PT WAS NOT SATISFIED WITH THE PERFORMANCE OF THE STAYFUSE IMPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R