BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M.U.S.T. PEDICLE SCREWS SYSTEM

    MDR report key: 23510652 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01102
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    July 17, 2024
    Report Date
    March 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630542704499
    PMA / PMN Number
    K234048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TORQUE LIMITER HANDLES VERIFICATION: THREE TORQUE LIMITER HANDLES WERE RECEIVED (USED FOR SET SCREWS FIXATION) AND SUBJECTED TO TORQUE VERIFICATION TESTING. THE RESULTS OF THE ANALYSIS DID NOT REVEAL ANY EVIDENCE OF INSUFFICIENT TORQUE APPLICATION. BASED ON THESE FINDINGS, THE REPORTED SET SCREW LOOSENING CANNOT BE ATTRIBUTED TO INADEQUATE TORQUE DELIVERY BY THE TORQUE LIMITER HANDLES. ROOT CAUSE: NO DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED WITH THE AVAILABLE INFORMATION, WHILE THE OVERALL ANALYSIS DID NOT REVEAL ANY MANUFACTURING OR PRODUCT-RELATED ISSUES.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-10-2025 PEDICLE SCREW 03.68.381 MUST POLYAXIAL CAN SCREW D 6X40 - D 5.5/6 (K234048) LOT 2329180: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 27-FEB-2024 EXPIRATION DATE: 2029-02-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.68.382 MUST POLYAXIAL CAN SCREW D 6X45 - D 5.5/6 (K234048) LOT 2329181: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-FEB-2024 EXPIRATION DATE: 2029-30-01. 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. 8 SCREWS ARE LISTED IN THIS COMPLAINT FROM 2 DIFFERENT LOT, IT IS UNKNOWN WHICH SCREW PRESENTS THE UNSCREWING CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT AFTER A SPINE FUSION SURGERY FROM L2 TO L5, THE PATIENT CAME FOR A ROUTINE FOLLOW-UP X-RAY, WHICH REVEALED A DISLOCATION OF A SET SCREW FROM THE CORRESPONDING TULIP SCREW. THE PATIENT DID NOT REPORT ANY SYMPTOMS. THE AVAILABLE IMAGING CONFIRMS THE DISLOCATION OF THE SET SCREW FROM ONE OF THE TWO MOST PROXIMAL TULIP SCREWS. DETERMINING THE CAUSE OF THIS FAILURE IS CHALLENGING BASED ON THE AVAILABLE INFORMATION. THE MOST LIKELY HYPOTHESIS COULD BE AN ISSUE DURING THE LOCKING MANEUVER, ALTHOUGH THIS REMAINS UNCERTAIN. HOWEVER, CONSIDERING THAT THE SET SCREW IS NOW FREELY LOCATED WITHIN THE SOFT TISSUES, WE CANNOT EXCLUDE THE POSSIBILITY OF SECONDARY MIGRATION. MOREOVER, THE OVERALL CONSTRUCT HAS A REDUCED MECHANICAL STRENGTH, AS ONE OF THE ROD HAS LOST ITS PROXIMAL ANCHORAGE. FOR THESE REASONS, POTENTIAL SECONDARY COMPLICATIONS CANNOT BE EXCLUDED. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO ESTABLISH A DEFINITIVE ROOT CAUSE, WHILE THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    PATIENT UNDERWENT SPINE FIXATION SURGERY (L2-L5) ON THE (B)(6) 2024. POST-OP FOLLOW-UP XRAY SHOWED DISLOCATION OF A SET SCREW FROM THE CONSTRUCT. IT CANNOT BE CONFIRMED FROM WHICH SCREW THE SETSCREW DETACHED. PATIENT DOES NOT REPORT ANY PAIN AND CURRENTLY NO REVISION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2615169 M.U.S.T. PEDICLE SCREWS SYSTEM MUST POLYAXIAL CANN SCREW Ø6X40 - Ø5.5/6 NKB MEDACTA INTERNATIONAL SA 03.68.381 2329180 07630542704499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention