BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICKX LOCKING CAP FOR TI3-D HEAD

    MDR report key: 2862796 · Received December 10, 2012

    Report

    Report Number
    8030965-2012-01492
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    NQP
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THIS EVENT INVOLVED A BROKEN N-HANCE ROD BUT THERE IS NO MENTION OF THE CLICK¿X PEDICLE SCREWS OR CAPS PLAYING A ROLE. THE ORIGINAL REASON FOR TREATMENT AND THE IMPLANTATION TECHNIQUES THAT WERE USED ARE UNKNOWN. THE RODS FRACTURED IN A LOCATION WHERE THERE IS BOTH A THIN CROSS SECTION AND A FEATURE ACTING AS A STRESS RISER. THE DEVICE MAY HAVE BEEN SUBJECTED TO APPLIED STRESSES OR CYCLES THAT EXCEEDED THE IMPLANT'S ABILITY TO RESIST. THE PORTIONS OF THE RODS THAT DO NOT CONTAIN THE FLEXIBLE COMPONENTS HAVE SLIGHT MARKS FAIRLY CLOSE TO THE FRACTURE THAT SUGGEST THE MIDDLE SCREWS WERE LOCKED FAIRLY CLOSE TO THE FLEXIBLE COMPONENTS. THE PEDICLE SCREWS APPEAR TO BE IN GOOD STRUCTURAL CONDITION. THE RODS HAVE BEEN DAMAGED BUT THIS PRODUCT HAS SHOWN A PAST SENSITIVITY TO IMPLANTATION TECHNIQUE. THE IMPLANTATION TECHNIQUES THAT WERE BEING USED TO IMPLANT THESE DEVICES ARE UNKNOWN. WITH SO LITTLE KNOWN ABOUT THE IMPLANTATION TECHNIQUE A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING A PATIENT IMPLANTED IN 2008 WITH CLICK X DEVICE AND TWO NFLEX RODS WHO PRESENTED POST-OPERATIVELY WITH BACK PAIN. UPON REVISION, IT WAS REPORTED THAT THE TWO NFLEX RODS WERE BROKEN AT THE L4-L5 LEVEL AND THAT L5-S1 WAS FUSED, L4-L5 WAS NOT FUSED. THE SURGEON REMOVED THE ENTIRE CLICK X IMPLANT AND TWO BROKEN NFLEX RODS RANGING FROM LEVEL L4 TO S1. THIS IS REPORT #12 OF 14 FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI CLICKX LOCKING CAP FOR TI3-D HEAD CLICKX LOCKING CAP NQP SYNTHES GMBH 1237278

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention