BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIO TRAUMA SCREW DIA 5.5 X 45 MM

    MDR report key: 4121876 · Received September 26, 2014

    Report

    Report Number
    0009617544-2014-00415
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    MNI
    PMA / PMN Number
    K103292
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE HISTORY REVIEW AND VISUAL INSPECTION. RESULTS: NO ISSUES WERE IDENTIFIED DURING MANUFACTURING RECORD REVIEW. VISUAL INSPECTION INDICATED RETURNED DEVICES WERE INSPECTED AND CONFIRMED TO BE BENT ON THE THREADED PORTION OF THE SCREW, CONFIRMING THE REPORTED EVENT. THE DEFORMATION APPEARED TO OCCUR NEAR THE TOP OF THE THREADED PORTION, WHICH SUGGESTS THAT THE SCREW WAS NOT FULLY INSERTED, AS ALL OF THE THREADING SHOULD BE BENEATH THE SURFACE OF THE PEDICLE. CONCLUSION: WITH THE SCREW NOT FULLY INSERTED DURING DISTRACTION, THE LOAD IS TRANSFERRED TO THE THREADED REGION AND NOT THE SHAFT, WHICH CAN LEAD TO ITS DEFORMATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS THAT THE SCREW WAS NOT FULLY INSERTED WITH THE THREADED PORTION FULLY EMBEDDED IN THE PEDICLE DURING DISTRACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON CHECKED ALIGNMENT AFTER 1ST KYPHOPLASTY, THE SURGEON DECIDED TO CORRECT MORE. SO AFTER THE 2ND KYPHOPLASTY, THE SURGEON CONFIRMED THAT BOTH SIDE T11 SCREWS WERE DEFORMING. THEREFORE ALL IMPLANTS WERE EXTRACTED, XIA3 IMPLANTS WERE USED AND THE SURGERY WAS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE SURGEON CHECKED ALIGNMENT AFTER 1ST KYPHOPLASTY, THE SURGEON DECIDED TO CORRECT MORE. SO AFTER THE 2ND KYPHOPLASTY, THE SURGEON CONFIRMED THAT BOTH SIDE T11 SCREWS WERE DEFORMING. THEREFORE ALL IMPLANTS WERE EXTRACTED, XIA3 IMPLANTS WERE USED AND THE SURGERY WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600918 TRIO TRAUMA SCREW DIA 5.5 X 45 MM IMPLANT-SCREW MNI STRYKER SPINE-FRANCE 68377

    Patients

    Seq Age Sex Outcome Treatment
    1