BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD

    MDR report key: 1901453 · Received November 11, 2010

    Report

    Report Number
    2520274-2010-00208
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    September 21, 2010
    Report Date
    October 12, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    NKB
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS DISCARDED BY THE HOSPITAL. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K) # WITHOUT A PART NUMBER OR LOT NUMBER. NO CONCLUSION COULD BE DRAWN AS THE DEVICE WAS DISCARDED BY THE HOSPITAL AND THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    A POSTOP CT SCAN FROM A DEGENERATIVE PANGEA CASE AT L4-S1 SHOWED THE ROD HAD MIGRATED CRANIALLY OUT OF THE SCREW AND LOCKING CAP INTERFACE. THE SURGEON REMOVED ALL THREE LOCKING CAPS, SCREWS AND ROD. PATIENT WAS RE-INSTRUMENTED USING LARGER DIAMETER SCREWS, THREE NEW LOCKING CAPS AND ONE NEW ROD. THIS IS THE 1ST OF 3 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROD ROD NKB SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS| LOCKING CAPS