BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. PEDICLE SCREW SYSTEM

    MDR report key: 22518024 · Received July 16, 2025

    Report

    Report Number
    3005180920-2025-00681
    Event Type
    Injury
    Date Received
    July 16, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 16, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWQ
    UDI-DI
    07630971279162
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 07 JULY 2025. MUST LT 03.59.025 MUST LT 15MM LONG - PEDICLE SCREW Ø6X45 CANN LOT 2323299: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2023. EXPIRATION DATE: 26-APRIL-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED: BATCH REVIEW PERFORMED ON 07 JULY 2025 MUST LT 03.59.025 MUST LT 15MM LONG - PEDICLE SCREW Ø6X45 CANN (K203482) LOT 2324236 X2 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-AUG-2023. EXPIRATION DATE: 14-AUG-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW (2 DEVICES INVOLVED IN THIS COMPLAINT). BATCH REVIEW PERFORMED ON 07 JULY 2025 MUST LT 03.59.035 MUST LT 15MM LONG - PEDICLE SCREW Ø7X45 CANN (K203482) LOT 2326318 X2 : (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-SEPT-2023. EXPIRATION DATE: 28-AUG-2028. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW (2 DEVICES INVOLVED IN THIS COMPLAINT). CONCLUSIONS: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE 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 1 YEAR AND 2 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING BACK PAIN. SURGEON REMOVED TWO RIGHT-SIDE SCREWS AND ADDED BONE GRAFT. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162754 M.U.S.T. PEDICLE SCREW SYSTEM MUST LT 15MM LONG - PEDICLE SCREW Ø6X45 CANN KWQ MEDACTA INTERNATIONAL SA 03.59.025 2323299 07630971279162

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention