BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2820658 · Received October 31, 2012

    Report

    Report Number
    2520274-2012-02794
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    September 24, 2012
    Report Date
    October 24, 2012
    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

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) PROVIDES INFO FROM A FACILITY IN (B)(4) REGARDING A REVISION PROCEDURE (UNK DATE); ARTHRODESIS, REQUIRED DUE TO LOOSENING OF ROD SCREWS, BILATERALLY AT S1. THE RODS LEFT AND RIGHT DROPPED/SLID OUT OF THE HEAD (LOCKING CAPS WERE STILL ATTACHED). THERE WAS NO BREAKAGE OF THE IMPLANT. METALLOSIS PRESENCE OF BILATERAL REGION AND PSEUDOARTHROSIS WERE NOTED. THIS IS REPORT #1 OF 6 FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A REVISION ARTHRODESIS, AS THE LOCKING CAP ON SCREWS S1 (BILATERAL) CAME LOOSE. THE RODS LEFT AND RIGHT SLID OUT OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN CLICKX SCREW NKB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention