BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THOR THORACOLUMBAR PLATE 48MM

    MDR report key: 3000575 · Received March 12, 2013

    Report

    Report Number
    0009617544-2013-00069
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 12, 2013
    Manufacturer
    STRYKER SPINE-FRANCE
    Product Code
    KWQ
    PMA / PMN Number
    D059389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE STILL IMPLANTED.

    Additional Manufacturer Narrative · 1

    METHOD: DEVICE INSPECTION; RISK ASSESSMENT. RESULTS: IT HAS BEEN CONFIRMED THAT THE THOR SCREW IS BACKING OUT OF THE THOR THORACOLUMBAR PLATE UPON VISUAL INSPECTION VIA THE X-RAY PHOTOS PROVIDED. THE PRODUCT WAS NOT RETURNED AND MAY STILL BE IMPLANTED IN THE PATIENT. A POSSIBLE CAUSE FOR THIS EVENT MAY BE DUE TO IMPROPER SCREW INSERTION. THE SURGICAL TECHNIQUE STATES, "PLEASE ENSURE THAT THE STANDARD SCREWS ARE FULLY SEATED INTO THE LOCKING RINGS OF THE PLATE." IF THE SCREWS WERE NOT SEATED PROPERLY INTO THE LOCKING RINGS, IT COULD RESULT IN THE SCREW POSSIBLY BACKING OUT OF THE PLATE AS SEEN IN THIS EVENT, HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED. CONCLUSION: THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AND IS LIKELY MULTIFACTORIAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ON FOLLOW-UP OPERATIVE VISIT, DR NOTICED ON HIS X-RAYS THAT A SCREW IS BACKING OUT OF THE THOR PLATE ... DR PLANS TO CLOSELY WATCH HER X-RAYS TO MAKE SURE THE SCREW DOES NOT MOVE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "ON FOLLOW-UP OPERATIVE VISIT DR. (B)(6) NOTICED ON HIS X-RAYS THAT A SCREW IS BACKING OUT OF THE THOR PLATE ... DR. (B)(6) PLANS TO CLOSELY WATCH HER X-RAYS TO MAKE SURE THE SCREW DOES NOT MOVE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104037 THOR THORACOLUMBAR PLATE 48MM THORACOLUMBAR PLATE KWQ STRYKER SPINE-FRANCE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 480316549