BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. POLYAXIAL PEDICLE SCREW

    MDR report key: 20544242 · Received October 28, 2024

    Report

    Report Number
    3005180920-2024-00872
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    September 30, 2024
    Report Date
    October 28, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MNI
    UDI-DI
    07630030834196
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7 OCTOBER 2024. LOT 1924046: 9 ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2020. EXPIRATION DATE: 2025-JAN-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 6 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS REVISED. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.016 PEDICLE SCREW 6X35 (K121115) LOT. 2023369. LOT 2023369: 55 ITEMS MANUFACTURED AND RELEASED ON 11-JAN-2021. EXPIRATION DATE: 2025-DEC-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 49 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.016 PEDICLE SCREW 6X35 (K121115) LOT. 2023955. LOT 2023955: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2025-DEC-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. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.016 PEDICLE SCREW 6X35 (K121115) LOT. 2120720. LOT 2120720: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAR-2021. EXPIRATION DATE: 2026-FEB-17. 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. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.017 PEDICLE SCREW 6X40 (K121115) LOT. 2021953. LOT 2021953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-SEP-23. 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. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.017 PEDICLE SCREW 6X40 (K121115) LOT. 2120724. LOT 2120724: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2021. EXPIRATION DATE: 2026-FEB-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. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON PEDICLE SCREW 03.50.454 BENT ROD TI 5.5X55MM (K121115) LOT. 2322413. LOT 2322413: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2023. EXPIRATION DATE: 2028-APR-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 (2 DEVICES INVOLVED IN THIS COMPLAINT). BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON MECTALIF POSTERIOR (TI PEEK) 03.27.114 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 9X22X11 L5° (K181970) LOT. 2223875, LOT 2223875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2022. EXPIRATION DATE: 2027-JUN-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 (2 DEVICES INVOLVED IN THIS COMPLAINT). BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON MECTALIF POSTERIOR (TI PEEK) 03.27.114 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 9X22X11 L5° (K181970) LOT. 2226587 LOT 2226587: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2022. EXPIRATION DATE: 2027-JUN-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. BATCH REVIEW PERFORMED ON 7 OCTOBER 2024 ON MECTALIF POSTERIOR (TI PEEK) 03.27.114 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 9X22X11 L5° (K181970) LOT. 2228508 LOT 2228508: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-FEB-2023. EXPIRATION DATE: 2028-JAN-29. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE LOT HAS BEEN SOLD.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 20 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REMOVED ALL IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1891226 M.U.S.T. POLYAXIAL PEDICLE SCREW SPINE PEDICLE SCREW MNI MEDACTA INTERNATIONAL SA 03.50.016 1924046 07630030834196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention