BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 5645754 · Received May 10, 2016

    Report

    Report Number
    3004717358-2016-00001
    Event Type
    Malfunction
    Date Received
    May 10, 2016
    Date of Event
    April 13, 2016
    Report Date
    May 6, 2016
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M824A5ST301
    PMA / PMN Number
    K150417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW WAS CONDUCTED OF ALL APPLICABLE MATERIAL, MANUFACTURING, STORAGE AND DISTRIBUTION RECORDS. THE RECORDS INDICATED THAT ALL PRODUCT LOTS FOR THIS ITEM SHIPPED 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 COMMONLY 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. IT IS UNKNOWN WHAT PREVENTED "PROPER" CONTACT BETWEEN THE SET SCREW AND THE ROD DURING THE FINAL TIGHTENING OF SET SCREW. 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

    SURGEON PERFORMED A REVISION SURGERY ON (B)(6) 2016 TO REPLACE A SET SCREW THAT WAS DISCOVERED TO BE LOOSE. THE ORIGINAL SURGERY WAS COMPLETED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298500 ASTRA SPINE SYSTEM SET SCREW NKB SPINECRAFT 92115 M824A5ST301

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention