BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI 3-D HEAD FOR TI CLICK'X SCREWS

    MDR report key: 2150684 · Received June 24, 2011

    Report

    Report Number
    1719045-2011-00323
    Event Type
    Injury
    Date Received
    June 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    MNI
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED. APPROXIMATE IMPLANT DATE REPORTED AS 2002. DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MFG DATE WITHOUT A LOT NUMBER. ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT STATUS POST POSTERIOR LUMBAR FUSION, IMPLANTED WITH RODS, SCREWS AND LOCKING CAPS AT L3-L5 IN 2002. PT BECOME MYELOPATHIC AND SURGEON NOTED NERVE ROOT AT L4 WAS INFLAMED AND ADJACENT LEVEL DISEASE AT L2. PT RETURNED TO OPERATING ROOM. RODS AND LOCKING CAP WERE REMOVED, SCREWS ADDED TO L2, NEW RODS AND CAPS PLACED, SURGERY COMPLETED. THIS IS THE 19TH OF 20 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI 3-D HEAD FOR TI CLICK'X SCREWS 3-D HEAD MNI SYNTHES MONUMENT NA NI

    Patients

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