BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM

    MDR report key: 24826099 · Received April 9, 2026

    Report

    Report Number
    3005180920-2026-00274
    Event Type
    Injury
    Date Received
    April 9, 2026
    Date of Event
    March 16, 2026
    Report Date
    April 9, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293588
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 18 MARCH 2026. PEDICLE SCREW 03.58.246 MUST MC SCREW D 6X50 CANNULATED (K210427) LOT 2327392: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-OCT-2023. EXPIRATION DATE: 2028-09-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.58.246 MUST MC SCREW D 6X50 CANNULATED (K210427) LOT 2321445: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2023. EXPIRATION DATE: 2028-04-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM.TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, ALTHOUGH IT IS POSSIBLE TO HYPOTHESIZE THAT A PRIMARY FACTOR OF THE THE LOOSENING WAS THE POOR PATIENT BONE QUALITY. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO TWO SCREWS THAT WERE LOOSE AT THE L2 LEVEL. THE SURGEON OBSERVED THAT THERE WAS POOR BONE QUALITY. THE SURGEON REMOVED THE TWO SCREWS AND EXTENDED THE RODS IN THE CONSTRUCT UP TO THE T12 LEVEL, BUT LEFT SCREWS OUT OF THE L2 LEVEL DUE TO THE BONE QUALITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887167 M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM MUST MC SCREW Ø6X50 CANNULATED NKB MEDACTA INTERNATIONAL SA 03.58.246 2327392 07630971293588

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention