BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTRA SPINE SYSTEM

    MDR report key: 7872734 · Received September 13, 2018

    Report

    Report Number
    3004717358-2018-00001
    Event Type
    Malfunction
    Date Received
    September 13, 2018
    Date of Event
    August 13, 2018
    Report Date
    September 12, 2018
    Manufacturer
    SPINECRAFT
    Product Code
    NKB
    UDI-DI
    M824A5P7545
    PMA / PMN Number
    K150417
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON CONFIRMED THAT THE PATIENT WAS PROGRESSING TOWARDS SUCCESSFUL FUSION, BECAUSE OF WHICH, HE DID NOT WANT TO PERFORM A REVISION SURGERY AT THIS TIME. THE SPECIFIC LOT WAS OBTAINED FROM THE SURGERY CHARGE SHEET AND A THOROUGH REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT WAS CONDUCTED AND IDENTIFIED NO DEVIATIONS OR ANOMALIES. THIS IS THE FIRST TIME THIS TULIP DISENGAGEMENT WAS REPORTED SINCE THE LAUNCH OF THIS PRODUCT SYSTEM IN 2015. A ROOT CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION AVAILABLE. WE WILL FURTHER OUR INVESTIGATION IF AND WHEN SPINECRAFT RECEIVES THE EXPLANTED IMPLANTS OR IF ADDITIONAL INFORMATION BECAME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    AT ABOUT 5 MONTHS POST-OP, PATIENT HAD A FALL AND WENT BACK FOR A REVIEW. FROM THE X-RAY, IT WAS SEEN THAT THE PATIENT HAS A POSSIBLE FRACTURE AT L4 VERTEBRAL BODY, AND FOR ONE OF THE SCREWS THE TULIP WAS DISENGAGED FROM THE SHAFT. PATIENT REPORTED SOME PAIN; HOWEVER, THE SOURCE OF THE PAIN WAS UNCLEAR. AT THIS TIME, THERE IS NO REVISION SURGERY SCHEDULED, AND THE DEVICE REMAINS IMPLANTED. PATIENT WILL CONTINUE TO BE MONITORED BY THE SURGEON FOR AT LEAST 6 WEEKS. IT IS REPORTED THAT REVISION SURGERY IS TO BE CONSIDERED IF AFTER THE FRACTURE HEALS, THE PATIENT STILL CONTINUES TO HAVE PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714093 ASTRA SPINE SYSTEM SCREW NKB SPINECRAFT 137205 M824A5P7545

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR