BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.2MM TI CLICK''X® PEDICLE SCR DUAL CORE 45MM THREAD LENGTH

    MDR report key: 2925978 · Received January 22, 2013

    Report

    Report Number
    8030965-2013-00206
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CLICKX IMPLANT AT L4-L5 ON AN UNKNOWN DAY IN 2007. ON AN UNKNOWN DATE, PATIENT COMPLAINED OF BACK PAIN AND REQUESTED TO HAVE THE HARDWARE REMOVED. PATIENT RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. DURING THIS PROCEDURE SURGEON DISCOVERED ONE SCREW WAS BROKEN AT THE TOP OF THE HEAD AT AN UNKNOWN PEDICLE LOCATION. ALL HARDWARE WAS REMOVED AND REPLACED WITH MATRIX RODS AND SCREWS. THIS IS 1 OF 12 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29314 6.2MM TI CLICK''X® PEDICLE SCR DUAL CORE 45MM THREAD LENGTH SCREW NKB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention RODS, LOCKING CAPS