BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    MDR report key: 23583105 · Received November 18, 2025

    Report

    Report Number
    3005180920-2025-01136
    Event Type
    Injury
    Date Received
    November 18, 2025
    Date of Event
    October 31, 2025
    Report Date
    December 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293564
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: -D9: DEVICES WERE SENT BACK AND A VISUAL INSPECTION WAS PERFORMED. THE SCREWS BROKE UNDER THE SPHERICAL HEAD. SIGN ARE PRESENT BELOW THE FRACTURE ZONE AND AT THE START OF THE THREAD PROBABLY CAUSED DURING REMOVAL. THE BREAKAGE MAY HAVE BEEN CAUSED BY FAILED VERTEBRAL FUSION DUE TO THE PATIENT'S CONDITION, WHICH FORCED THE CONSTRUCT TO SUSTAIN CYCLIC LOADING FOR MONTHS, ULTIMATELY CAUSING THE MATERIAL TO FAIL DUE TO FATIGUE DURING THE REVISION SURGERY, THE CONSTRUCT HAS BEEN EXTENDED TO S1 WITHOUT REPLACING THE LEFT L5 SCREW. - X-RAYS WERE PROVIDED AND A CLINICAL EVALUATION WAS PERFORMED. A REVISION SURGERY WAS PERFORMED APPROXIMATELY SIX MONTHS AFTER THE L3-L5 SPINAL FUSION DUE TO PERSISTENT PATIENT PAIN. DURING THE PROCEDURE, THREE PEDICLE SCREWS WERE FOUND TO BE FRACTURED, A FINDING THAT IS ALSO CONFIRMED BY THE AVAILABLE CT IMAGES. FATIGUE FRACTURE OF PEDICLE SCREWS IS A WELL-KNOWN OCCURRENCE WHEN SOLID FUSION HAS NOT BEEN ACHIEVED AND THE INSTRUMENTATION IS SUBJECTED TO CONTINUOUS MECHANICAL STRESS. CONSIDERING THE REPORTED FAILURE OF BONE FUSION, THIS APPEARS TO BE THE MOST LIKELY CLINICAL CAUSE OF THE SCREW FRACTURES.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05-11-2025. PEDICLE SCREW 03.58.244 MUST MC SCREW D 6X40 CANNULATED (K210427) LOT: 2464126: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-NOV-2024 EXPIRATION DATE: 2029-11-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES FROM THIS LOT INVOLVED IN THIS COMPLAINT. PEDICLE SCREW 03.58.244 MUST MC SCREW D 6X40 CANNULATED (K210427) LOT: 2463772: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2024 EXPIRATION DATE: 2029-10-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE:THE SCREWS BREAKAGES WERE MOST LIKELY DUE TO A LACK OF BONE FUSION, WHICH RESULTED IN EXCESSIVE MECHANICAL LOADING ON THE IMPLANTS. WHILE THE EXACT ROOT CAUSE CANNOT BE DEFINITIVELY CONFIRMED, THE INVESTIGATION FOUND NO EVIDENCE OF MANUFACTURING DEFECTS OR SYSTEMIC ISSUES RELATED TO THE DEVICE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT SURGERY FOR VERTEBRAL FUSION L3-L5. 6 MONTHS AFTER PRIMARY THE PATIENT REPORTED PAIN. SURGEON PROCEEDED WITH REVISION AND FOUND 3 BROKEN SCREWS (L3-L4 RIGHT SIDE AND L5 ON THE LEFT SIDE). BREAKAGE OCCURRED AT THE BASE OF THE TULIP IN ALL SCREWS. IT WAS REPORTED THAT PATIENT'S BONE WAS ARTHRITIC AND THAT VERTEBRAL FUSION FAILED. CONSTRUCT WAS REVISED, SURGEON REPLACED THE SCREW IN L3-L5 ON THE RIGHT SIDE, REMOVED THE SCREW FROM LEFT L5 WHICH WAS NOT REPLACES, AND ADDED A SCREW IN LEFT S1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2236439 M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM MUST MC SCREW Ø6X40 CANNULATED NKB MEDACTA INTERNATIONAL SA 03.58.244 2464126 07630971293564

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention