BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MINI POLYAXIAL SCREW

    MDR report key: 22902796 · Received August 27, 2025

    Report

    Report Number
    3005180920-2025-00796
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    September 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030863875
    PMA / PMN Number
    K171369
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 JUL 2025. MUST MINI 03.75.209 MUST MINI CANN.POLY. SCREW-FULL THR-4.0X28+NUT (K171369) LOT. 2462499: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2024. EXPIRATION DATE: 2029-09-04. 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 MINI 03.75.209 MUST MINI CANN.POLY. SCREW-FULL THR-4.0X28+NUT (K171369) LOT. 2460852: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-JUL-2024. EXPIRATION DATE: 2029-06-30. 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 MINI 03.75.209 MUST MINI CANN.POLY. SCREW-FULL THR-4.0X28+NUT (K171369) LOT 2127542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2022. EXPIRATION DATE: 2026-12-20. 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 MINI 03.75.209 MUST MINI CANN.POLY. SCREW-FULL THR-4.0X28+NUT (K171369) LOT 2126585: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2021. EXPIRATION DATE: 2026-11-29. 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 MINI 03.75.209 MUST MINI CANN.POLY. SCREW-FULL THR-4.0X28+NUT (K171369) LOT. 1922084B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2024. EXPIRATION DATE: 2029-10-14. 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. ONE OF THE FIVE SCREWS MENTIONED ABOVE IS INVOLVED. ALL BATCHES ARE BEING REPORTED, AS IT IS NOT YET KNOWN WHICH ONE IS INVOLVED. A CONCLUSION HAS YET TO BE ESTABLISHED AS THE DEVICES HAVE NOT BEEN RETURNED AND ANALYZED.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER. BASED ON THE EVENT DESCRIPTION, IT WAS SUPPOSED THAT THE THREADING INTERFACE OF THE DEVICE WAS DAMAGED DUE TO A CROSS-THREADING, CAUSING THE LOOSENING OF THE SETSCREW COMPONENT. A VISUAL INSPECTION AND A FUNCTIONAL TEST WERE PERFORMED ON THE RETRIEVED DEVICE: NO VISUAL DEFECTS WERE OBSERVED. THE THREADING PROFILE WAS AS GOOD AS INTACT AND IT WAS POSSIBLE TO LOAD AND FIX THE SETSCREW UNDER 3NM TORQUE AS PER STANDARD PROCEDURE. IN CONCLUSION, IT WAS NOT POSSIBLE TO IDENTIFY THE ROOT CAUSE THAT LED TO THE SETSCREW LOOSENING FROM THE TULIP COMPONENT. CONCLUSIONS: THE DEVICE WAS FOUND TO BE IN ACCORDANCE WITH SPECIFICATIONS, WITH NO DEFECTS DETECTED, AND THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE. ALTHOUGH THE SPECIFIC CIRCUMSTANCES CANNOT BE VERIFIED, IT IS MOST LIKELY THAT UNIQUE APPLICATION-SPECIFIC FACTORS, SUCH AS INSUFFICIENT TIGHTENING TORQUE AT THE TIME OF DEVICE APPLICATION, CONTRIBUTED TO THE REPORTED ISSUE.

    Description of Event or Problem · 0

    PRIMARY SURGERY WAS PERFORMED AT C2-C7 WITH MYSPINE CERVICAL GUIDE ON (B)(6). A CT SCAN TWO WEEKS AFTER SURGERY SHOWED NO PROBLEMS, BUT THREE WEEKS AFTER SURGERY, IT WAS DISCOVERED THAT THE SET SCREW AT THE RIGHT SIDE OF C7 HAD COME LOOSE. REVISION SURGERY WAS PERFORMED AFTER TWO MONTHS TO REPLACE WITH THE NEW SET SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1250582 M.U.S.T. MINI POLYAXIAL SCREW MUST MINI CANN.POLY.SCREW-FULL THR-4.0X28+NUT KWP MEDACTA INTERNATIONAL SA 03.75.209 2462499 07630030863875

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention