BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 1903462 · Received November 15, 2010

    Report

    Report Number
    2520274-2010-00206
    Event Type
    Injury
    Date Received
    November 15, 2010
    Report Date
    October 27, 2010
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. IMPLANT DATE REPORTED AS 8-10 YEARS AGO. MANUFACTURE SITE AND MANUFACTURE DATE CANNOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    A PATIENT IMPLANTED WITH UNASSEMBLED CLICK'X APPROXIMATELY 8-10 YEARS AGO AT L4-S1 WITH NO INSTRUMENTATION PLACED IN L5, WAS RETURNED TO THE OPERATING ROOM IN (B)(6), 2010 FOR REVISION. PATIENT WAS IMPLANTED WITH 6.2MM X 45MM SCREWS X 2, 7.0MM SCREWS X 2, 3-D HEADS X 4, LOCKING CAPS X 4 AND 2 RODS. AT SOME POINT POST-IMPLANT IT WAS NOTED THE RODS HAD SLIPPED FROM THE SCREWS. ALL HARDWARE WAS REMOVED AND PATIENT WAS NOTED TO BE FUSED AT L5-S1. PATIENT WAS REVISED TO NEW PREASSEMBLED CLICK'X HARDWARE AT L3-L4. THIS REPORT IS #9 OF 10 FOR THE SAME EVENT.

    Devices

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

    Patients

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