BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M.U.S.T. PEDICLE SCREW SYSTEM

    MDR report key: 24051153 · Received January 13, 2026

    Report

    Report Number
    3005180920-2026-00010
    Event Type
    Malfunction
    Date Received
    January 13, 2026
    Date of Event
    December 15, 2025
    Report Date
    January 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630542704482
    PMA / PMN Number
    K234048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16-DEC-2025. MUST LT 03.68.380 MUST POLYAXIAL CANN SCREW D 6X35 - D 5.5/6 (K234048) LOT. 2329179: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2024. EXPIRATION DATE: 2029-02-04. 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 03.68.380 MUST POLYAXIAL CANN SCREW D 6X35 - D 5.5/6 (K234048) LOT. 2464191: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-NOV-2024. EXPIRATION DATE: 2029-11-04. 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:ALTHOUGH IT IS NOT POSSIBLE TO CONFIRM, THE DAMAGE OF THE THREADS LIKELY INVOLVED A SUBOPTIMAL ALIGNMENT OF THE COMPONENTS DURING THE FIRST ATTEMPT AT ENGAGEMENT. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING-RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Additional Manufacturer Narrative · 0

    ON 20-JAN-2026 WE WERE INFORMED THAT THE DEVICES INVOLVED IN THIS EVENT WERE NOT AVAILABLE FOR INSPECTION. DIFFERENTLY FROM WHAT WAS INITALLY COMUNICATED. FIELD D9 HAS BEEN UPDATED ACCORDINGLY.

    Description of Event or Problem · 0

    THE SURGEON COULD NOT TIGHTEN THE SET SCREWS (USINGTHE FINAL TIGHTENER FROM MUST 2.0) ONTO THE TULIP OF TWO 6.0X35MM SCREWS, AS THE THREAD KEPT STRIPPING. NO DIFFERENT SETSCREW WAS USED BEFORE REMOVING THE PEDICLE SCREWS. THE PEDICLE SCREWS WERE EXPLANTED, AND 6.0X40MM PEDICLE SCREWS WERE INSERTED. THERE WAS A 30-MINUTE DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114997 M.U.S.T. PEDICLE SCREW SYSTEM MUST POLYAXIAL CANN SCREW Ø6X35 - Ø5.5/6 NKB MEDACTA INTERNATIONAL SA 03.68.380 2329179 07630542704482

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Other