BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1829886 · Received September 7, 2010

    Report

    Report Number
    9610726-2010-00279
    Event Type
    Death
    Date Received
    September 7, 2010
    Date of Event
    August 9, 2010
    Report Date
    August 19, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFO PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, "ON (B)(6) 2010, THE PRIMARY PLIF SURGERY (FIXATION FROM L2 TO L4) WAS PERFORMED LOT L3 COMPRESSION FRACTURE. THE IMPLANTS USED WERE THE SYNTHES' PANGEA AND THE CAGE THAT WAS GOING TO BE USED WAS VBOSS (STRYKER PRODUCT). THE BONE CEMENT USED WAS SIMPLEX P (STRYKER PRODUCT). AFTER IMPLANTING THE PANGEA SYSTEM TO L2 - L4, THE L3 VERTEBRA WAS REMOVED. (SIMPLEX P BONE CEMENT WAS USED WHEN PLACING CEMENT INTO L4 PEDICLE.). THEN THE SURGEON WAS PUTTING THE BONE GRAFT INTO THE VBOSS, THE PT DIED BEFORE PLACING THE VBOSS TO THE PT. THE SURGEON HAD PERFORMED SOME SURGERY IN THE SIMILAR WAY IN THE PAST. THE SURGEON DID NOT KNOW THAT THE USE OF SIMPLEX P FOR SPINE IS OUT OF INDICATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death