BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRYKER OPERATING ROOM SYSTEM II SURGICAL NAVIGATION SYSTEMS

    MDR report key: 2234430 · Received August 30, 2011

    Report

    Report Number
    MW5021979
    Event Type
    Other
    Date Received
    August 30, 2011
    Date of Event
    November 19, 2009
    Report Date
    August 17, 2011
    Manufacturer
    STRYKER INSTRUMENTS
    Product Code
    HAW
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NECK OPERATION USING A STRYKER TABLE AT (B)(6) HOSPITAL IN (B)(6) 2009 - DAMAGED VOCAL CORDS. KNEE REPLACEMENT IN (B)(6) 2009 USING STRYKER TABLE AT (B)(6) HOSPITAL. KNEE WOULD NOT HEAL BECAUSE A 3 INCH PIECE OF MENISCUS CARTILAGE WAS CAUGHT IN THE REPLACEMENT KNEE. I HAD TO HAVE THE REPLACEMENT KNEE COMPLETELY REVISED AND REPLACED IN (B)(6) 2011. THIS IS WHEN THE PROBLEM WAS DIAGNOSED. THE VOCAL CORDS WILL PROBABLY NEED WORK ON THEM IN THE NEAR FUTURE. THE DOCTORS ASKED ME TO WAIT FOR 2 YEARS TO SEE IF THEY WOULD HEAL ON THEIR OWN, BUT THEY DON'T SEEM TO BE DOING SO. I THINK EITHER STRYKER CORP. DID NOT NOTIFY (B)(6) HOSPITAL OF A PROBLEM WITH THEIR PROGRAM (OR DID NOT KNOW THE PROGRAM (B)(6) IS USING IS DEFECTIVE) OR (B)(6) HOSPITAL WAS UNABLE TO QUARANTINE THEIR TABLE DURING (B)(6) 2009 WITHOUT UNDUE MONETARY PROBLEMS THEREFORE CAUSING MANY PATIENTS TO HAVE PROBLEM WHICH THEIR DOCTORS WERE NOT AWARE COULD HAPPEN. I MET TOO MANY PEOPLE IN THERAPY SESSIONS THAT WERE ALSO HAVING UNNECESSARY PROBLEMS BUT THOUGHT THIS WAS "NORMAL." I HAVE NO IDEA WHAT CAN BE DONE ABOUT THIS OTHER THAN TO REPORT IT TO YOU PEOPLE AND HOPE YOU'LL CHECK INTO IT. THANK YOU FOR ANY ATTENTION YOU GIVE TO THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRYKER OPERATING ROOM SYSTEM II SURGICAL NAVIGATION SYSTEMS NAVIGATION SYSTEM II-CART HAW STRYKER INSTRUMENTS S 100715-100735
    2 STRYKER OPERATING ROOM SYSTEM II SURGICAL NAVIGATION SYSTEMS PC SPC-1 ASSEMBLY HAW STRYKER INSTRUMENTS K7P00F6000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other