BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 4232186 · Received November 6, 2014

    Report

    Report Number
    0009617544-2014-00465
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    March 15, 2012
    Report Date
    October 7, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE NO DEVICES WERE RECEIVED FOR EVALUATION, TESTING AND INSPECTION CANNOT BE PERFORMED TO AID IN ROOT CAUSE ANALYSIS.CONCLUSION:BECAUSE NO DEVICES HAVE BEEN RECEIVED, THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED CONCLUSIVELY.

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY "THE PATIENT UNDERWENT SURGERY WHEREIN A STRYKER XIA PEDICLE SYSTEMS WITH ILIAC FIXATION WAS INSERTED INTO PATIENT'S LUMBAR SPINE". IT IS FURTHER ALLEGED THAT "THE RODS OF THE PRODUCT BROKE CAUSING SEVERE AND PERMANENT PERSONAL INJURIES".

    Description of Event or Problem · 1

    IT WAS REPORTED THROUGH THE FILING OF A LAWSUIT THAT ALLEGEDLY "THE PATIENT UNDERWENT SURGERY WHEREIN A STRYKER XIA PEDICLE SYSTEMS WITH ILIAC FIXATION WAS INSERTED INTO PATIENT'S LUMBAR SPINE". IT IS FURTHER ALLEGED THAT "THE RODS OF THE PRODUCT BROKE CAUSING SEVERE AND PERMANENT PERSONAL INJURIES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713392 UNKNOWN_SPINE_PRODUCT IMPLANT NKB STRYKER SPINE-FRANCE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention