BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 7937073 · Received October 4, 2018

    Report

    Report Number
    3004717358-2018-00002
    Event Type
    Malfunction
    Date Received
    October 4, 2018
    Date of Event
    September 6, 2018
    Report Date
    October 4, 2018
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M824A5P85801
    PMA / PMN Number
    K150417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW EXPLANTED AFTER THE REVISION SURGERY WAS RETURNED TO SPINECRAFT AND INVESTIGATION WAS PERFORMED. BENCH TESTING WAS CONDUCTED ON SEVERAL SCREWS FROM OR ASSOCIATED WITH THE SAME COMPONENTS USED IN INCIDENT LOT TO CHALLENGE THE ASSEMBLY. ALL SCREWS WERE ABLE TO WITHSTAND OVER 21 NM TIGHTENING TORQUE OF THEIR SET SCREWS, WHICH IS DOUBLE THE SET SCREW NORMAL TIGHTENING TORQUE, WITHOUT DISENGAGEMENT OF THE SCREWS HEADS (TULIPS). THE USAGE HISTORY WAS ALSO REVIEWED FOR THIS LOT OF THE SCREWS AND THIS SHOWED THAT NO INCIDENT HAS BEEN REPORTED IN REGARD TO THIS LOT OR OTHER LOTS USING COMPONENTS ASSOCIATED WITH THE SAME. MULTIPLE REPRESENTATIVE LOTS OF ASSEMBLY COMPONENTS ASSOCIATED WITH THE EXPLANTED SCREW WERE RE-INSPECTED AND NO DEVIATIONS WERE FOUND. A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO DEVIATIONS OR ANOMALIES WERE IDENTIFIED. THE TOLERANCE ANALYSIS FOR DESIGN WAS ALSO REVIEWED AND NO FAULTS WERE FOUND. THE ROOT CAUSE OF THE REPORTED FAILURE CANNOT BE DETERMINED AT THIS TIME AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED. WE CAN PRESUME HOWEVER THAT LOAD FORCE EXCEEDING THE LOAD CAPACITY OF THE SCREW WAS PROBABLY ENCOUNTERED POST-OP, WITH THE SUBSEQUENT FAILURE OF THE BOTTOM RING. IF ADDITIONAL INFORMATION BECAME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS FOUND TWO WEEKS POST-OP ON X-RAY THAT AN ILIAC SCREW HEAD AT THE BOTTOM OF A LONG CONSTRUCT WAS DISENGAGED FROM THE SHAFT. THE SURGEON DECIDED TO PERFORM A REVISION SURGERY AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774223 ASTRA SPINE SYSTEM A5P-8580 NKB SPINECRAFT 111032 M824A5P85801

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR