BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASYS SCREW

    MDR report key: 624955 · Received August 4, 2005

    Report

    Report Number
    9617544-2005-00056
    Event Type
    Other
    Date Received
    August 4, 2005
    Date of Event
    June 27, 2005
    Report Date
    July 5, 2005
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    HWC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN HAVING NUMBNESS IN BOTH HANDS AFTER A WEEK FROM THE SURGERY. THE SURGEON CHECKED THE X-RAY AND IT SEEMED THAT THE SCREW AT C2 AND C3 HAD A NARROWER ANGLE THAT THE FIRST DAY OF SURGERY. ALSO IT SEEMS THAT THE C5 AND C6 ARE HAVING SPONDYLOISTHESIS FROM THE X-RAY. THE SCREW WERE INITIALLY PLACED AT 90 DEGREES (PERPENDICULAR) TO THE ROD; HOWEVER, A WEEK LATER IT HAS ABOUT 80 DEGREES. HOWEVER, THERE IS NO BACKOUT AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS SCREW IMPLANT HWC STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other