BEUDAMED
    FDA Adverse Event Injury Summary report: N

    N FLEX ROD 150MM

    MDR report key: 1640069 · Received March 19, 2010

    Report

    Report Number
    1719045-2010-00051
    Event Type
    Injury
    Date Received
    March 19, 2010
    Date of Event
    July 1, 2009
    Report Date
    August 27, 2009
    Manufacturer
    SYNTHES (USA)
    Product Code
    NQP
    PMA / PMN Number
    K061774
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS MFG BY N-SPINE. AS OF MARCH 2008, N-SPINE IS PART OF SYNTHES AND THE CURRENT EQUIVALENT OF THIS DEVICE IS PRODUCED BY SYNTHES (B) (4). INVESTIGATION IS IN PROCESS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. DEVICE HISTORY HAS BEEN REQUESTED AND WILL PROVIDE THE DATE OF MFR.

    Description of Event or Problem · 1

    PT WAS IMPLANTED WITH TWO 150MM N FLEX RODS (L5-S1 FUSION, L4-L5 DYNAMIC) ON (B) (6) 2008. IN (B) (6) 2009, PT BEGAN TO EXPERIENCE DISCOMFORT AND BOTH RODS WERE FOUND TO HAVE BROKEN AT THE DYNAMIC LEVEL. THE BROKEN RODS WERE EXPLANTED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N FLEX ROD 150MM TI N-FLEX RODS NQP SYNTHES (USA) NA PO7M03

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention N FLEX ROD