BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEX-D2, SET SCREW, BLUNT START, T-30 HEXALOBE

    MDR report key: 24119160 · Received January 20, 2026

    Report

    Report Number
    3010020754-2026-00001
    Event Type
    Injury
    Date Received
    January 20, 2026
    Date of Event
    March 3, 2025
    Report Date
    January 20, 2026
    Manufacturer
    NEXT ORTHOSURGICAL
    Product Code
    NKB
    UDI-DI
    00840314141798
    PMA / PMN Number
    K190981
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NEXT ORTHOSURGICAL INC. RECEIVED A COMPLAINT ON (B)(6) 2025, REPORTING THAT A PATIENT WHO UNDERWENT LUMBAR SPINAL SURGERY ON (B)(6) 2024, WAS LATER FOUND TO HAVE DISLODGEMENT OF AN IMPLANTED SET SCREW ASSOCIATED WITH A THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM AT THE L4 LEVEL. THE DISLODGEMENT WAS CONFIRMED BY THE TREATING PHYSICIAN ON (B)(6) 2025. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DURING WHICH THE AFFECTED PEDICLE SCREW, SET SCREW, AND ROD WERE REMOVED AND REPLACED WITH AN UPSIZED PEDICLE SCREW AND NEW ROD AND SET SCREW. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY. THE AFFECTED COMPONENT WAS IDENTIFIED AS A SET SCREW, BLUNT START (PART NO. CBCAJ-10000), LOT NO. 003552A03. THE DEVICE HISTORY RECORD FOR THE AFFECTED LOT WAS REVIEWED AND CONFIRMED THAT THE PRODUCT MET ALL APPLICABLE INSPECTION AND RELEASE CRITERIA. NO PHYSICAL DEVICE SAMPLE WAS RETURNED FOR EVALUATION, AND THERE WAS NO REMAINING INVENTORY AVAILABLE FROM THE AFFECTED LOT TO PERMIT ADDITIONAL PHYSICAL INSPECTION OR MATERIAL ANALYSIS. AS A RESULT, THE SPECIFIC FAILURE MECHANISM COULD NOT BE CONCLUSIVELY CONFIRMED. IMAGES PROVIDED WITH THE ORIGINAL COMPLAINT SHOWED SURFACE MARKINGS SUCH AS FADING AND ABRASION, WHICH CAN OCCUR DURING SURGICAL USE. NO INDICATIONS OF BREAKAGE WERE OBSERVED AT THE THREADS OF EITHER THE PEDICLE SCREW TULIP OR THE SET SCREW. BASED ON PREDOMINANTLY CLINICAL INFORMATION PROVIDED IN THE ORIGINAL COMPLAINT, THE EVENT MAY BE RELATED TO PROCEDURAL FACTORS; HOWEVER, THIS COULD NOT BE CONFIRMED. ALTHOUGH NO PRODUCT MALFUNCTION WAS VERIFIED, THE EVENT MET THE CRITERIA FOR MEDICAL DEVICE REPORTING DUE TO THE REQUIREMENT FOR ADDITIONAL SURGICAL INTERVENTION AND IS BEING REPORTED IN ACCORDANCE WITH 21 CFR PART 803. NO CORRECTIVE OR PREVENTIVE ACTION WAS INITIATED. THE COMPLAINT WILL BE CLOSED BASED ON THE INFORMATION CURRENTLY AVAILABLE. THE MANUFACTURER WILL CONTINUE TO MONITOR SIMILAR EVENTS THROUGH POST-MARKET SURVEILLANCE AND TRENDING, AND THE COMPLAINT RECORD WILL BE UPDATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A PATIENT WHO UNDERWENT SPINAL SURGERY ON (B)(6) 2024, WAS LATER FOUND TO HAVE DISLOCATION OF THE L4 RIGHT SET SCREW ASSOCIATED WITH THE IMPLANTED PEDICLE SCREW SYSTEM. ON (B)(6) 2025, THE TREATING PHYSICIAN CONFIRMED THE DISLOCATION. AS A RESULT, A SECOND SURGICAL INTERVENTION WAS PERFORMED ON (B)(6), 2025, DURING WHICH THE L4 RIGHT PEDICLE SCREW, SET SCREW, ROD, AND THE L5 RIGHT ROD AND SET SCREW WERE REMOVED. THE L4 PEDICLE SCREW WAS REPLACED WITH AN UPSIZED 7.8 Ã 50 MM PEDICLE SCREW, AND FINAL FIXATION WAS ACHIEVED USING A NEW ROD AND SET SCREW. THE RE-OPERATION WAS COMPLETED SUCCESSFULLY. NO DEVICE SAMPLE WAS AVAILABLE FOR RETURN OR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178291 NEX-D2, SET SCREW, BLUNT START, T-30 HEXALOBE THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB NEXT ORTHOSURGICAL CBCAJ-10000 003552A03 00840314141798

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other