BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 6431316 · Received March 24, 2017

    Report

    Report Number
    3004717358-2017-00001
    Event Type
    Malfunction
    Date Received
    March 24, 2017
    Date of Event
    February 24, 2017
    Report Date
    February 24, 2017
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M824A5ST301
    PMA / PMN Number
    K150417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL, MANUFACTURING, STORAGE AND DISTRIBUTION RECORDS FOR THE DEVICE RELATED TO THIS INCIDENT, THE ASSOCIATED DEVICE AND THE TORQUE LIMITING HANDLES USED TO TIGHTEN THE SCREW. THE RECORDS INDICATED THAT ALL PRODUCT LOTS FOR THESE ITEMS WERE MANUFACTURED WITHIN SPECIFICATION, MAINTAINED AND DISTRIBUTED IN ACCORDANCE WITH ALL APPROVED COMPANY PROCEDURES. DEVICE EVALUATION OF THE RETURNED DEVICE AND A CONTROLLED DEVICE FROM THE SAME LOT WAS PERFORMED IN AN ATTEMPT TO REPLICATE CONDITIONS NECESSARY TO CREATE A SCENARIO WHERE REPORTED EVENT IS POSSIBLE. DURING FINAL TIGHTENING OF SET SCREWS, IT HAS BEEN NORMALLY OBSERVED THAT THE ROD CREATES A SWEEPING BURNISH MARK ON THE BOTTOM SURFACE OF THE SET SCREW AKIN TO A WINDSHIELD WIPER MARK. HOWEVER, THIS MARK WAS DISTINCTLY MISSING ON THE SET SCREW RELATED TO THIS INCIDENT. THIS UNMARKED AREA WOULD SUGGEST THAT THE SET SCREW NEVER EXPERIENCED PROPER FINAL TIGHTENING. THE REMAINING MARKINGS WOULD HAVE BEEN CAUSED BY THE MOVEMENT OF THE ROD, ONCE LOOSENING PROPAGATED. ALSO, IT CAN BE NOTED THAT THERE IS NO SPECIFIC DAMAGE TO THE THREADS, WHICH WOULD BE EXPECTED IF THERE WAS CROSS-THREADING OR SOME OTHER EVENT THAT WOULD HAVE HINDERED THE SET SCREW FROM SEATING AGAINST THE ROD DURING FINAL TIGHTENING. AT THIS TIME, THERE ARE NO OTHER KNOWN FACTORS THAT WOULD HAVE PREVENTED THE SET SCREW FROM TIGHTENING AGAINST THE ROD. BASED ON THE EVIDENCE FROM THE OBSERVATIONS AND TESTING PERFORMED, NO PROBABLE ROOT CAUSE(S) FOR THIS INCIDENT COULD BE DETERMINED UNTIL AND UNLESS FURTHER INFORMATION BECOMES AVAILABLE. THEREFORE, NO CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. THE PATIENT WAS REVISED SUCCESSFULLY AND IS REPORTEDLY DOING WELL.

    Description of Event or Problem · 1

    IT WAS DISCOVERED ON A POST-OP FOLLOW UP VISIT THAT ONE OF THE SET SCREWS IS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213471 ASTRA SPINE SYSTEM SET SCREW NKB SPINECRAFT 120529 M824A5ST301

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention A5P-6545E-C