BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2

    MDR report key: 19914111 · Received August 5, 2024

    Report

    Report Number
    3010020754-2024-00003
    Event Type
    Injury
    Date Received
    August 5, 2024
    Date of Event
    November 29, 2021
    Report Date
    August 5, 2024
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    NKB
    PMA / PMN Number
    K190981
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCTION LOT RECORDS WERE REVIEWED AND THERE WERE NO ABNORMALITIES INDICATING MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS. THERE ARE NO TRENDS OR ADDITIONAL ADVERSE EVENTS FOR THIS PRODUCTION LOT. INVESTIGATION IS STILL ONGOING, BUT INITIAL INVESTIGATIVE RESULTS LEAD TO UNAPPROVED USAGE OF DEVICE WITH COMPETITOR PRODUCT. BASED ON THE INITIAL DETAILS, THE ROOT CAUSE HAS BEEN ATTRIBUTED TO A USER RELATED ISSUE. IF FURTHER INFORMATION IS PROVIDED, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 0

    SET SCREW DEVICE WAS FOUND LOOSE DURING A FOLLOW-UP TO OPERATION PERFORMED ON (B)(6) 2021. THE DEVICE HAD BEEN IMPLANTED ALONG WITH ANOTHER COMPANY DEVICE "MEDTRONIC BALLAST SAI SCREW". THAT DEVICE WAS ALSO LOOSE. REOPERATION AND REMOVAL OF LOOSE DEVICES WERE PERFORMED ON (B)(6) 2021 AND THE REPORTED DEVICE ALONG WITH TWO OTHERS FROM THE SAME PRODUCTION LOT WERE REPLACED WITH NEW ONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1675492 NEX-D2 SET SCREW, BLUNT START NKB NEXT ORTHOSURGICAL CBCAJ-10000 U020491A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Prefer Not To Disclose Required Intervention MEDTRONIC BALLAST SAI SCREW