BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3649962 · Received February 27, 2014

    Report

    Report Number
    0009617544-2014-00089
    Event Type
    Injury
    Date Received
    February 27, 2014
    Date of Event
    January 29, 2014
    Report Date
    January 29, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW; RESULTS: THE CUSTOMER REPORTED XIA 3 DEVICE ISSUE WAS NOT CONFIRMED, AS NO INFORMATION HAS BEEN MADE AVAILABLE AND NO DEVICES HAVE BEEN RETURNED THAT COULD AID IN CONFIRMATION OF THE EVENT. AS A RESULT, IT IS UNKNOWN, WHICH XIA 3 DEVICES ARE IN QUESTION AND WHAT THEIR REPORTED FAILURE MODES WERE. CONCLUSION: THIS LACK OF INFORMATION, A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A POSTERIOR L4-S1 DECOMPRESSION AND INSTRUMENTED FUSION OPERATION AND WAS IMPLANTED WITH THE STRYKER XIA 3 INSTRUMENTATION. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT A LUMBAR SPINE CT ON (B)(6) 2011, WHICH REVEALED ISSUES WITH THE XIA 3 INSTRUMENTATION AND COMPONENT PARTS, WHICH REQUIRED AN ANTERIOR FUSION TO THE LUMBAR SPINE IN (B)(6) 2012 AND ANOTHER SURGERY IN (B)(6) 2013 TO REMOVE PORTIONS OF THE STRYKER XIA 3 INSTRUMENTATION. ,

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY THE PATIENT UNDERWENT A POSTERIOR L4-S1 DECOMPRESSION AND INSTRUMENTED FUSION OPERATION AND WAS IMPLANTED WITH THE STRYKER XIA 3 INSTRUMENTATION. IT IS FURTHER ALLEGED THAT THE PATIENT UNDERWENT A LUMBAR SPINE CT ON (B)(6) 2011 WHICH REVEALED ISSUES WITH THE XIA 3 INSTRUMENTATION AND COMPONENT PARTS, WHICH REQUIRED AN ANTERIOR FUSION TO THE LUMBAR SPINE IN (B)(6) 2012 AND ANOTHER SURGERY IN (B)(6) 2013 TO REMOVE PORTIONS OF THE STRYKER XIA 3 INSTRUMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120651 UNKNOWN_SPINE_PRODUCT UNK NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention