BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. PEDICLE SCREW SYSTEM

    MDR report key: 23081977 · Received September 18, 2025

    Report

    Report Number
    3005180920-2025-00846
    Event Type
    Injury
    Date Received
    September 18, 2025
    Date of Event
    August 20, 2025
    Report Date
    September 18, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278448
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2025: MUST LT 03.57.033 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X35 CANN LOT 2562202: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16/07/2025. EXPIRATION DATE: 22/06/2030. 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. ADDITIONAL DEVICES INVOLVED, BATCH REVIEW PERFORMED ON 04 SEPTEMBER 2025: MUST LT 03.57.033 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X35 CANN (K203482) LOT 2561628: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20/06/2025. EXPIRATION DATE: 05/06/2030. 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. MUST LT 03.57.034 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X40 CANN (K203482) LOT 2560859: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28/05/2025. EXPIRATION DATE: 13/05/2030. 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. MUST LT 03.57.034 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X40 CANN (K203482) LOT 2559466: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11/04/2024. EXPIRATION DATE: 24/03/2030. 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. PEDICLE SCREW 03.51.10.0625 TORQUE LIMITER HANDLE 9NM - EXTENSION COMPATIBLE LOT 2156153: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2022. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS DEPARTMENT: A SET SCREW DISENGAGED IMMEDIATELY AFTER AN L4-L5 SPINAL FUSION SURGERY. POSTOPERATIVE RADIOGRAPHIC IMAGES CLEARLY CONFIRMED THE OCCURRENCE. THE FINAL TIGHTENING WAS REPORTEDLY PERFORMED CORRECTLY, AND STABILITY WAS CHECKED BEFORE WOUND CLOSURE. IDENTIFYING A DEFINITIVE EXPLANATION REMAINS CHALLENGING. ONE HYPOTHESIS IS THAT THE LEFT ROD, BEING SLIGHTLY LONG, MAY HAVE INTERFERED WITH THE PROXIMAL ANATOMICAL STRUCTURES, PREVENTING COMPLETE SEATING INTO THE TULIP. CONSEQUENTLY, REMOVAL OF THE EXTENDED TAP MAY HAVE EXPOSED THE LAST THREAD OF THE SET SCREW, LEADING TO LOOSENING OF THE FIXATION. FURTHER ANALYSIS OF THE INSTRUMENTS USED AND RETRIEVED COMPONENTS MAY PROVIDE ADDITIONAL INSIGHTS. THE PATIENT WAS SUCCESSFULLY REOPERATED ON IMMEDIATELY, WITH THE LOOSE SET SCREW REMOVED AND REPLACED WITHOUT COMPLICATIONS. PRELIMINARY INVESTIGATION PERFORMED BY R&D SPINE DIRECTOR: AS DISCUSSED WITH THE SURGEON, THE LEFT ROD LOOKS LONG; A POTENTIAL SCENARIO COULD BE THAT THE ROD INTERFERED WITH THE ANATOMY/BONE, WHICH DID NOT ALLOW TO GET THE ROD TO BE FULLY SEATED INSIDE THE TULIP WHEN APPLYING THE FINAL TIGHTENING. AS A CONSEQUENCE, THE SET SCREW POTENTIALLY CAME OFF WHEN THEY REMOVED THE EXTENDED TAP. VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE SETSCREW HAS BEEN MEASURED AND IS COMPLIANT WITH THE DRAWING. IT HAS BEEN TESTED IN A PEDICLE SCREW, AND FINAL TIGHTENING WAS SUCCESSFULLY ACHIEVED. ONE OF THE TABS SHOWS SMALL BURRS ON THE EXTERNAL SURFACE. ANOTHER TAB HAS ONE DEFORMED THREAD. THE TORQUE LIMITER HAS BEEN TESTED USING A CALIBRATED TORQUE TESTING MACHINE, AND THE MEASURED VALUES ARE WITHIN THE SPECIFIED TOLERANCE RANGE. A POSSIBLE CAUSE OF THE ISSUE IS THAT THE ROD INTERFERED WITH THE ANATOMY/BONE, PREVENTING IT FROM BEING FULLY SEATED INSIDE THE TULIP DURING FINAL TIGHTENING AND/OR THE SETSCREW MAY HAVE BEEN IN A CROSS-THREADED POSITION. AS A RESULT, WHEN THE EXTENSION TAB BROKE, THE SETSCREW CAME OFF. THE POSSIBILITY OF THE TULIP OPENING DURING TAB BREAKAGE IS CONSIDERED LESS LIKELY, AS IN THAT CASE, FINAL TIGHTENING WOULD NOT HAVE BEEN ACHIEVABLE THE SECOND TIME. CONCLUSION: A PLAUSIBLE INTRAOPERATIVE SCENARIO IS THAT THE ROD IMPINGED ON THE ADJACENT BONY OR ANATOMICAL STRUCTURES, HINDERING ITS COMPLETE SEATING WITHIN THE TULIP DURING THE FINAL TIGHTENING STEP. CONSEQUENTLY, UPON REMOVAL OF THE EXTENDED TAP, THE SET SCREW MAY HAVE DISENGAGED.

    Description of Event or Problem · 0

    FIXATION L4-L5. AFTER SURGERY, IT WAS RECOGNISED THAT A SET SCREW CAME OFF. THE PATIENT WAS IMMEDIATELY REOPERATED AND THE SETSCREW REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634889 M.U.S.T. PEDICLE SCREW SYSTEM MUST LT 15MM SHORT - PEDICLE SCREW Ø7X35 CANN NKB MEDACTA INTERNATIONAL SA 03.57.033 2562202 07630971278448

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention