BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAV

    MDR report key: 2980731 · Received February 27, 2013

    Report

    Report Number
    8030965-2013-00636
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED A PATIENT WAS IMPLANTED WITH CLICK'X CONSTRUCT AT L4-L5. THE PATIENT REPORTEDLY FELL 4 MONTHS POST OPERATIVE. THE RODS APPEARED TO BE LOOSE AND AFTER EXPOSURE IT WAS CONFIRMED THAT THE ROD ON THE LEFT AND ON THE RIGHT WERE NOT LOCKED DOWN INTO THE SCREW HEADS. THE ROD WAS MOBILE IN THE SCREW HEADS BELOW THE LOCKING CAPS. THE CONSTRUCT WAS REMOVED. STABILITY OF PLIF LEVEL, L4-L5, WAS EVALUATED AND REPLACEMENT OF THE SCREWS WAS CONSIDERED NOT NECESSARY AT THIS POINT IN TIME. THIS REPORT IS #1 OF 6 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85387 CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAV 3-D HEAD NKB SYNTHES GMBH 7528330

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention