BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIA 3 TITANIUM BLOCKER

    MDR report key: 3317899 · Received August 29, 2013

    Report

    Report Number
    3005525032-2013-00084
    Event Type
    Malfunction
    Date Received
    August 29, 2013
    Date of Event
    July 31, 2013
    Report Date
    July 31, 2013
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    MNH
    PMA / PMN Number
    K071373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: VISUAL INSPECTION; FUNCTIONAL INSPECTION; DEVICE HISTORY REVIEW; COMPLAINT HISTORY REVIEW; RISK ASSESSMENT; RESULTS: THE RETURNED DEVICE WAS CONFIRMED TO BE A XIA 3 TITANIUM BLOCKER, CATALOG # 48230000, LOT #KXT. MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT # KXT AND NO RELATED NONCONFORMITIES WERE IDENTIFIED DURING PRODUCTION. ALL UNITS PASSED INSPECTION AND MET STRYKER SPECIFICATIONS. THE RETURNED BLOCKER WAS INSPECTED AND TWO SLIGHT DENTS WERE IDENTIFIED. THE DENTS WERE, ASYMMETRICAL AND LOCATED ONLY ON ONE SIDE OF THE BLOCKER, SUGGESTING UNEQUAL LOAD APPLIED TO EACH SIDE OF THE BLOCKER. THE DENTS WERE LOCATED ON ONE SIDE OF THE BLOCKER BASE. THIS IS POSSIBLY DUE TO THE ROD NOT BEING SEATED COMPLETELY PERPENDICULAR TO THE TULIP, WHICH MAY HAVE CAUSED THE ROD TO SIGNIFICANTLY IMPACT ONLY ONE END OF THE BLOCKER. THE BLOCKER WAS SUCCESSFULLY THREADED INTO A XIA 3 TITANIUM POLY AXIAL SCREW AND UNTHREADED WITHOUT ISSUE. CONCLUSION: HOWEVER, BECAUSE ONLY THE BLOCKER WAS RETUNED FOR EVALUATION IT CANNOT BE DETERMINED IF ANY OF THE STATED EXPLANATIONS WERE THE LIKELY CAUSE OF THE EVENT. THE RELATED ROD REMAINS IMPLANTED IN THE PATIENT AND IS UNAVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A XIA 3 SURGERY THE BLOCKER CAME LOOSE. IT WAS REPLACED WITH ANOTHER BLOCKER AND THE SURGERY WAS FINISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A XIA 3 SURGERY THE BLOCKER CAME LOOSE. IT WAS REPLACED WITH ANOTHER BLOCKER AND THE SURGERY WAS FINISHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425242 XIA 3 TITANIUM BLOCKER SURGICAL BLOCKER MNH STRYKER SPINE-SWITZERLAND UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR