BEUDAMED
    FDA Adverse Event Death Summary report: N

    5.5MM HEX-END ROD 500MM

    MDR report key: 2880905 · Received December 20, 2012

    Report

    Report Number
    8030965-2012-01617
    Event Type
    Death
    Date Received
    December 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    SYNTHES GMBH
    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 13 OF 18 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM HEX-END ROD 500MM HEX-END ROD NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Death