BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. POLYAXIAL PEDICLE SCREW

    MDR report key: 23510664 · Received November 10, 2025

    Report

    Report Number
    3005180920-2025-01088
    Event Type
    Injury
    Date Received
    November 10, 2025
    Date of Event
    October 20, 2025
    Report Date
    November 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857577
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL EVALUATION PERFORMED BY MEDACTA MEDICAL AFFAIRS MANAGER: THE AVAILABLE IMAGES CONSIST OF ONLY TWO CT SCAN SLICES, WHICH MAKES IT QUITE CHALLENGING TO CONFIRM THE REPORTED SCREW MOBILIZATION OR TO IDENTIFY ANY SIGNS OF INFECTION. HOWEVER, DELAYED INFECTION FOLLOWING SPINAL FUSION SURGERY IS A WELL-DOCUMENTED ADVERSE EVENT DESCRIBED IN THE LITERATURE. AT PRESENT, THERE IS NO REASON TO SUSPECT THAT THE CAUSE IS RELATED TO THE IMPLANTED DEVICES. BATCH REVIEWS PERFORMED ON 27 OCTOBER 2025: PEDICLE SCREW 03.52.322 ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE (K141988) LOT 2324078: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-JUN-05. 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 03.52.322 ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE (K141988) LOT 2323578: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-JUN-2023. EXPIRATION DATE: 2028-MAY-21. 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 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT 2321377: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-APR-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. PEDICLE SCREW 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT 2325799: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEP-2023. EXPIRATION DATE: 2028-AUG-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. PEDICLE SCREW 03.50.450 BENT ROD TI 5.5 X 35MM - STERILE (K121115) LOT 2126659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JAN-2022. EXPIRATION DATE: 2026-DEC-21. 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 03.50.451 BENT ROD TI 5.5 X 40MM - STERILE (K121115) LOT 2323419: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUN-2023. EXPIRATION DATE: 2028-MAY-15. 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. ROOT CAUSE: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 5 MONTHS POST PRIMARY THE SURGEON OBSERVED THAT THE SCREWS WERE LOOSE DUE TO THE INFECTION. THE SURGEON REVISED THE SCREWS AND THE RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616116 M.U.S.T. POLYAXIAL PEDICLE SCREW ENH. CANN. PEDICLE SCREW 6X35MM + NUT (1X) STERILE NKB MEDACTA INTERNATIONAL SA 03.52.322 2323578 07630030857577

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention