BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 3953924 · Received July 23, 2014

    Report

    Report Number
    0009617544-2014-00317
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE DEVICE WAS NOT RECEIVED, TESTING AND INSPECTION CANNOT BE PERFORMED TO AID IN ROOT CAUSE DETERMINATION. HOWEVER, PER THE COMMUNICATION WITH THE SALES REPRESENTATIVE, THE DEVICE WAS IMPLANTED FOR APPROXIMATELY 3 MONTHS AND UNION HAD NOT OCCURRED. THIS MEANS THAT THE CONSTRUCT WOULD HAVE BEEN TASKED TO BEAR THE WEIGHT OF THE SPINE WITHOUT ADDITIONAL SUPPORT. THE XIA 3 IFU STATES THAT "THE COMPONENTS CANNOT BE EXPECTED TO INDEFINITELY WITHSTAND THE ACTIVITY LEVEL AND LOADS OF NORMAL HEALTHY BONE." CONCLUSION: THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS A FATIGUE FRACTURE OF THE DEVICE DUE TO A LACK OF FUSION AT THE SITE SUBJECTING THE ROD TO EXCESSIVE PHYSIOLOGICAL LOADS FOR A PROLONGED PERIOD OF TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NONUNION AND BROKE BOTH RODS AND XIA 3 ILIAC BOLT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NONUNION AND BROKE BOTH RODS AND XIA 3 ILIAC BOLT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431838 UNKNOWN_SPINE_PRODUCT IMPLANT NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention