BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORACLE PLATE IMPLANT AND INSTRUMENT SET

    MDR report key: 1614867 · Received February 19, 2010

    Report

    Report Number
    2520274-2010-00026
    Event Type
    Death
    Date Received
    February 19, 2010
    Date of Event
    January 22, 2010
    Report Date
    January 22, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K091159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. MFR SITE AND MFR DATE CANNOT BE DETERMINED WITHOUT A LOT #. SET IS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT # WAS PROVIDED. MFR RECORDS CANNOT BE REVIEWED WITHOUT A LOT #.

    Description of Event or Problem · 1

    SYNTHES SALES CONSULTANT REPORTED: ON (B) (6) 2010, A (B) (6) MALE UNDERWENT L3-L4 FUSION WITH ORACLE PLATING THROUGH A FULL LATERAL APPROACH. THE SURGEON USED INTRAOPERATIVE FLUOROSCOPY TO VIEW PLACEMENT OF THE LAST (FOURTH) SCREW AND DETERMINED THAT THE ANGULATION OF THE FOURTH SCREW WAS INCORRECT AND MADE A DECISION TO REMOVE IT. DURING REMOVAL OF THE FOURTH SCREW, THE SURGEON NOTED INCREASED BLOOD LOSS. THE SURGEON ATTEMPTED TO ACHIEVE HEMOSTASIS. AT THIS POINT, THE SALES CONSULTANT LEFT THE OPERATING ROOM. ON JAN 23, 2010, THE SALES CONSULTANT LEARNED THAT THE PT DIED. ON JAN 26, 2010, THE SALES CONSULTANT WAS TOLD BY THE PHYSICIAN'S ASSISTANT THAT: CARDIOVASCULAR SURGERY WAS CONSULTED, THE PT ACHIEVED STABILITY AND WAS TAKEN TO THE RECOVERY ROOM WHERE THE PT WAS EXTUBATED. THE PT EXPERIENCED FURTHER INSTABILITY AND BLEEDING AND WAS RETURNED TO THE OR WHERE STABILITY WAS ACHIEVED. THE PT WAS DISCHARGED TO THE INTENSIVE CARE UNIT. ON JAN 26, 2010, THE SURGEON REPORTED THE FOLLOWING INFO TO SYNTHES' PRODUCT DEVELOPMENT: ANTERIOR BOTTOM L4 SCREW VEERED OFF BONE INTO VENA CAVA. AFTER BLEEDING BEGAN, SURGERY WAS CONVERTED TO FULL ANTERIOR APPROACH FOR PURPOSE OF ACHIEVING HEMOSTASIS. PT RECEIVED 50 UNITS OF BLOOD. PT WAS TRANSFERRED TO THE RECOVERY ROOM POSTOP, THEN WAS EMERGENTLY RETURNED TO THE OR FOR EXPLORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ORACLE PLATE IMPLANT AND INSTRUMENT SET ORACLE SET KWQ SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death