BEUDAMED
    FDA Adverse Event Death Summary report: N

    5.5MM TI MATRIX REDUCTION SCREW 35MM THREAD LENGTH

    MDR report key: 2880895 · Received December 20, 2012

    Report

    Report Number
    2530088-2012-01111
    Event Type
    Death
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

     DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SCREWS, LOCKING CAPS, PEDICLE HOOKS, LAMINA HOOKS, HEX-END RODS, S-RODS, CONNECTORS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH MATRIX CONSTRUCT FOR FUSION AT T2-S1 ON (B)(6) 2012. IT WAS REPORTED THE PATIENT EXPIRED ON (B)(6) 2012. THE CAUSE OF DEATH IS CURRENTLY UNKNOWN AND IS UNDER INVESTIGATION AT THE TIME OF THIS REPORT.   THIS IS 1 OF 18 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM TI MATRIX REDUCTION SCREW 35MM THREAD LENGTH TI MATRIX REDUCTION SCREW NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death