BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIA LP MONOAXIAL SCREW 6.5 X 45MM

    MDR report key: 5574784 · Received April 13, 2016

    Report

    Report Number
    3005525032-2016-00039
    Event Type
    Injury
    Date Received
    April 13, 2016
    Date of Event
    March 17, 2016
    Report Date
    March 17, 2016
    Manufacturer
    STRYKER SPINE-SWITZERLAND
    Product Code
    NKB
    PMA / PMN Number
    K013823
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE CUSTOMER REPORTED EVENT WAS CONFIRMED VIA THE CORRESPONDENCE WITH THE INTERNATIONAL REPRESENTATIVE. HOWEVER, NO DEVICE WAS RECEIVED BACK, SO TESTING AND INSPECTION COULD NOT BE CONFIRMED. NO RELEVANT MANUFACTURING ISSUES WERE IDENTIFIED DURING REVIEW. CONCLUSION: BECAUSE ADDITIONAL FOLLOW UP AND THE CORRESPONDING PARTS WERE NOT AVAILABLE FOR REVIEW, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; STRYKER DISTRIBUTOR HAS RECEIVED A NOTICE FROM PATIENT'S LAWYER INFORMING THE PATIENT WILL NEED TO UNDERTAKE NEW SPINE SURGERY DUE TO BREAKAGE OF SPINE SCREW. REPORT DESCRIBED IN NOTICE RECEIVED: ON (B)(6) 2014 PATIENT WENT TO SURGERY DUE TO DIAGNOSIS OF CAUDA EQUINA SYNDROME (CES) ON L3/L4, IN CONJUNCTION WITH LUMBAR DISCOPATHY L2/L4, WHEN WAS IMPLANTED STRYKER IMPLANTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT; STRYKER DISTRIBUTOR HAS RECEIVED A NOTICE FROM PATIENT'S LAWYER INFORMING THE PATIENT WILL NEED TO UNDERTAKE NEW SPINE SURGERY DUE TO BREAKAGE OF SPINE SCREW. REPORT DESCRIBED IN NOTICE RECEIVED: ON (B)(6) 2014 PATIENT WENT TO SURGERY DUE TO DIAGNOSIS OF CAUDA EQUINA SYNDROME (CES) ON L3/L4, IN CONJUNCTION WITH LUMBAR DISCOPATHY L2/L4, WHEN WAS IMPLANTED STRYKER IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230491 XIA LP MONOAXIAL SCREW 6.5 X 45MM PEDICLE SCREW SPINAL SYSTEM NKB STRYKER SPINE-SWITZERLAND B33871

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention