BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. RODS

    MDR report key: 24738810 · Received March 31, 2026

    Report

    Report Number
    3005180920-2026-00262
    Event Type
    Injury
    Date Received
    March 31, 2026
    Date of Event
    March 10, 2026
    Report Date
    March 31, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835506
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 16 MAR 2026. PEDICLE SCREW 03.50.451 BENT ROD TI 5.5 X 40MM - STERILE (K121115) LOT 2323976: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2023. EXPIRATION DATE: 2028-JUN-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. (2 DEVICES INVOLVED IN THIS COMPLAINT) 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 ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.52.324 ENH. CANN. PEDICLE SCREW 6X45MM + NUT (1X) STERILE (K141988) LOT 2322205: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-MAR-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. PEDICLE SCREW 03.52.325 ENH. CANN. PEDICLE SCREW 6X50MM + NUT (1X) STERILE (K141988) LOT 2323175: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2023. EXPIRATION DATE: 2028-APR-24. 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

    AT1 YEAR 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED THE 5.5 X 40MM RODS TO RODS OF THE SAME SIZE, REVISED THE 6X45MM PEDICLE SCREWS TO THE SAME SIZE PEDICLE SCREWS, AND REVISED THE 6X50MM PEDICLE SCREW TO A 7X45MM PEDICLE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    802286 M.U.S.T. RODS BENT ROD TI 5.5 X 40MM - STERILE KWP MEDACTA INTERNATIONAL SA 03.50.451 2323976 07630030835506

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention