BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 2150692 · Received June 24, 2011

    Report

    Report Number
    2520274-2011-00222
    Event Type
    Injury
    Date Received
    June 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING SITE OR MANUFACTURING DATE WITHOUT A PART NUMBER OR A LOT NUMBER. SYNTHES IS UNABLE TO DETERMINE 510(K)# WITHOUT A PART NUMBER OR LOT NUMBER. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    PATIENT STATUS POST POSTERIOR LUMBAR FUSION, IMPLANTED WITH RODS, SCREWS AND LOCKING CAPS AT L3-L5 IN 2002. PATIENT BECOME MYLEOPATHIC AND SURGEON NOTED NERVE ROOT AT L4 WAS INFLAMED AND ADJACENT LEVEL DISEASE AT L2. PATIENT RETURNED TO OPERATING ROOM. RODS AND LOCKING CAP WERE REMOVED, SCREWS ADDED TO L2, NEW RODS AND CAPS PLACED, SURGERY COMPLETED. THIS IS THE 14TH OF 20 REPORTS SUBMITTED ON THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention RODS| 3-D HEADS| SCREWS| LOCKING CAPS