BEUDAMED
    FDA Adverse Event Other Summary report: N

    OASYS TI RODS

    MDR report key: 2549036 · Received April 19, 2012

    Report

    Report Number
    9617544-2012-00146
    Event Type
    Other
    Date Received
    April 19, 2012
    Date of Event
    March 23, 2012
    Report Date
    March 23, 2012
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWP
    PMA / PMN Number
    K032394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT IS FILED ON THE ALLEGED IMPLANTED OASYS TI RODS (CAT # CURRENTLY UNK). OTHER PRODUCTS - SPINAL CABLES, PART NUMBERS 312196, 312323; STRYKER BIOTECH CALSTRUX, LOT TU 27018; AND OP1 BONE GRAFT WERE ALSO IMPLANTED. IF PRODUCT BECOMES AVAILABLE AND LOT NUMBERS BECOME KNOWN FOR THESE OTHER PRODUCTS ASSOCIATED WITH THE INCIDENT THIS INFO WILL ALSO BE REPORTED AS SUPPLEMENTAL AND SEPARATE MDRS WILL BE FILED FOR THESE DEVICES. ADD'L INFO HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED AS SUPPLEMENTAL. METHOD, RESULT AND CONCLUSION CODES WILL BE MADE AVAILABLE FOLLOWING AN ENGINEERING EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "RECEIVED A CALL FROM (B)(6) OF (B)(6) SHE WAS ASKED FOR MORE INFO ABOUT PRODUCTS IMPLANTED FOUR YEARS AGO AT (B)(6) HOSPITAL IN (B)(6). SHE SPECIFICALLY WANTED TO KNOW THE METALLURGICAL/CHEMICAL COMPOSITION OF THE ITEMS. "SHE CLAIMED SHE WAS HAVING A TITANIUM REACTION WHICH WAS CAUSING HER TO HAVE SEIZURES AND ORGAN FAILURE. SHE ALSO COMPLAINED ABOUT THE SCREWS IN HER NECK STICKING OUT TO THE POINT SHE COULD FEEL THEM THROUGH THE SKIN. SHE CLAIMED THE SCREWS WERE CORRODING. SHE IS UNDER THE CARE OF DR. (B)(6). HE WAS NOT THE ORIGINAL IMPLANT SURGEON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OASYS TI RODS NONE KWP STRYKER SPINE BORDEAUX NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SPINAL CABLES: CAT # 312196| CAT # 312323| OP1 BONE GRAFT