BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA BLOCKER

    MDR report key: 1841407 · Received September 10, 2010

    Report

    Report Number
    9617544-2010-00366
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 24, 2010
    Report Date
    August 25, 2010
    Manufacturer
    STRYKER SPINE BORDEAUX
    Product Code
    KWQ
    PMA / PMN Number
    K060361
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF MADE AVAILABLE, WILL BE REPORTED IN A SUPPLEMENTAL. METHOD, RESULT, AND CONCLUSION WILL BE MADE AVAILABLE FOLLOWING ENGINEERING EVALUATION.

    Description of Event or Problem · 1

    DURING PLIF SURGERY FOR SPONDYLOLITHESIS AT L4/L5, ONE OF THE BLOCKER FRACTURED INTO TWO PIECES IN THE SCREW-HEADS (TULIP) WHILE FINAL TIGHTENING. THE SURGEON TRIED TO REMOVE THE FRACTURE BLOCKER WITH A TIGHTENER, HOWEVER, IT COULD NOT BE REMOVED, THEN THE SURGEON LEFT IT. THE SURGEON INQUIRED US TWO POINTS BELOW: THE POSSIBLE CAUSE OF THE BLOCKER'S FRACTURE. PLEASE ADVISE HOW SHOULD THE SURGEON REMOVE THE FRACTURED BLOCKER AND REVISE. SHOULD THE ROD BE CUT AND REMOVE THE ROD, THE SCREW, AND THE BLOCKER ALL TOGETHER? THIS IS IMPORTANT TO KNOW IN ORDER TO BE PREPARED IN CASE OF THE PATIENT WILL HAVE THE DEGENERATIVE CHANGE IN THE ADJUSTMENT SEGMENT FOR FUTURE AND WILL NEED THE REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIA BLOCKER IMPLANT KWQ STRYKER SPINE BORDEAUX NA V2B OR V7K

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR