BEUDAMED
    FDA Adverse Event Death Summary report: N

    NORIAN SRS BONE VOID FILLER ROTARY MIX 10CC-STERILE

    MDR report key: 2142471 · Received June 17, 2011

    Report

    Report Number
    2939274-2011-00006
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 10, 2011
    Manufacturer
    NORIAN CORPORATION
    Product Code
    MQV
    PMA / PMN Number
    K060408
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT#: THIS INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED: INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    SALES CONSULTANT REPORTED: PROXIMAL TIBIA LATERAL PLATEAU FRACTURE, IN AN (B)(6) PATIENT. SURGERY TOOK 4-5 HOURS TO COMPLETE. FIRST SURGEON PERFORMED DISSECTION AND WAS UNABLE TO ACHIEVE FRACTURE REDUCTION. SECOND SURGEON REDUCED FRACTURE, IMPLANTED PLATE WITH SCREWS AND INJECTED NORIAN INTO THE LATERAL PROXIMAL TIBIA. NO ABNORMAL BLEEDING WAS NOTED. THREE HOURS POSTOP PATIENT EXPIRED. THIS IS THE 1ST OF 10 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NORIAN SRS BONE VOID FILLER ROTARY MIX 10CC-STERILE SRS BONE VOID FILLER MQV NORIAN CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death PLATE| SCREWS