BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    M.U.S.T. PEDICLE SCREWS SYSTEM

    MDR report key: 23510654 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01101
    Event Type
    Malfunction
    Date Received
    November 10, 2025
    Date of Event
    October 16, 2025
    Report Date
    March 5, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630542704598
    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 ACTION CAN BE PLANNED AT THIS TIME AS NO ROOT CAUSE COULD BE IDENTIFIED WITH THE INFORMATION AVAILABLE, WHILE THE EVENT HAS BEEN INCLUDED IN OUR ACTIVE MONITORING SYSTEM FOR POTENTIAL CAPA NEEDS AND OPPORTUNITIES.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29-10-2025. PEDICLE SCREW 03.68.391 MUST POLYAXIAL CANN SCREW D 7X40 - D 5.5/6 (K234048) LOT 2458063: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-APR-2024 EXPIRATION DATE: 2029-03-07. 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 03.68.392 MUST POLYAXIAL CANN SCREW D 7X45 - D 5.5/6 (K234048) LOT 2458064: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-APR-2024 EXPIRATION DATE: 2029-03-06. 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 03.68.393 MUST POLYAXIAL CANN SCREW D 7X50 - D 5.5/6 (K234048) LOT 2329189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2024 EXPIRATION DATE: 2029-02-13. 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 03.68.393 MUST POLYAXIAL CANN SCREW D 7X50 - D 5.5/6 (K234048) LOT 2464193: (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. IT SHOULD BE NOTED THAT 6 SCREWS ARE LISTED IN THIS COMPLAINT FROM 4 DIFFERENT LOTS, IT IS UNKNOWN WHICH SCREW PRESENTS THE UNSCREWING CLINICAL EVALUATION PERFORMED BY CLINICAL AFFAIRS DEPARTMENT: AFTER A SPINE FUSION SURGERY FROM L3 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 (L3-L5) ON THE (B)(6) 2025. POST-OP FOLLOW-UP XRAY SHOWED DISLOCATION OF A SET SCREW FROM THE CONSTRUCT. ALTHOUGTH THE PROVIDED XRAY MAY SUGGEST THAT THE INVOLVED SCREW IS A Ø7X50 ONE, 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
    40269 M.U.S.T. PEDICLE SCREWS SYSTEM MUST POLYAXIAL CANN SCREW Ø7X40 - Ø5.5/6 NKB MEDACTA INTERNATIONAL SA 03.68.391 2458063 07630542704598

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention