BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2

    MDR report key: 22464873 · Received July 9, 2025

    Report

    Report Number
    3010020754-2025-00001
    Event Type
    Injury
    Date Received
    July 9, 2025
    Date of Event
    March 11, 2025
    Report Date
    May 22, 2025
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    NKB
    UDI-DI
    00840314141798
    PMA / PMN Number
    K190981
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED, DHR REVIEWED AND NO DEFECT FOUND, MARKINGS IN PHOTOS PROVIDED BY THE REPORTER PROVIDE EVIDENCE THAT THIS WAS CAUSED BY A LACK OF ENGAGEMENT WHEN TIGHTENING THE SCREW. SURGICAL PROCEDURE TECHNIQUE ISSUE / LACK OF PROPERLY FOLLOWING INSTRUCTIONS FOR USE.

    Description of Event or Problem · 0

    ON (B)(6) 2024, AN INITIAL OPERATION WAS PERFORMED ON A PATIENT EXTERNALLY FIXATING THE L4-L5 VERTEBRAE USING PEDICLE SCREWS. THEN ON (B)(6) 2025, THE DOCTOR CONFIRMED THAT THE L4 RIGHT SET SCREW WAS DISLOCATED. A REOPERATION WAS PERFORMED ON (B)(6) 2025 AND THE L4 RIGHT PEDICLE SCREW, SET SCREW, ROD, AND THE L5 RIGHT SET SCREW WERE REMOVED. THE PEDICLE SCREW WAS REPLACED WITH A LARGER OD USING SCREW SIZE 7.8 X 50 MM. THE ORIGINAL PEDICLE SCREW SIZE USED WAS A 7.0 X 50 MM. A NEW ROD AND SET SCREWS WERE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119014 NEX-D2 SET SCREW, BLUNT START NKB NEXT ORTHOSURGICAL CBCAJ-10000 003552A03 00840314141798

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention