BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20369755 · Received October 4, 2024

    Report

    Report Number
    3005180920-2024-00800
    Event Type
    Injury
    Date Received
    October 4, 2024
    Date of Event
    September 13, 2024
    Report Date
    November 7, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293663
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO ANALYSIS HAS BEEN POSSIBLE WITH THE AVAILABLE INFO. A FOLLOW UP MDR WILL BE PERFORMED WHEN/IF NEW INFO WILL BE AVAILABLE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 7-NOV-2024. LOT: 2321448: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAY-2023. EXPIRATION DATE: 2028-04-19. 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. ADDITIONAL IMPLANTS INVOLVED: PEDICLE SCREW 03.50.204 MUST COMBINED SETSCREW H4-T27 - (4X) K171758 LOT: 2458441. BATCH REVIEW PERFORMED ON 07-NOV-2024. (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-APR-2024. EXPIRATION DATE: 2029-04-01. 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: 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. UPDATED FIELDS: DATE OF THE EVENT, EVENT DESCRIPTION, BRAND NAME, COMMON DEVICE NAME, PRODUCT CODE, MODEL, LOT, EXPIRY DATE, UDI, MANUFACTURING DATE, ADDITIONAL MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    THE PATIENT UNDERGONE PRIMARY SURGERY ON THE (B)(6) 2024. REVISION SURGERY WILL BE PERFORMED DUE TO A MEDIAL DEVIATION OF L5 PEDICLE SCREW. NO ADDITIONAL INFO AVAILABLE AT NOW.

    Description of Event or Problem · 0

    THE PATIENT UNDERGONE PRIMARY SURGERY ON (B)(6) 2024. REVISION SURGERY HAS BEEN PERFORMED ON (B)(6) DUE TO A MEDIAL DEVIATION OF L5 PEDICLE SCREW. PEDICLE SCREW AND CONNECTORS REVISED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726192 M.U.S.T. MIDLINE CORTICAL (MC) SCREW SYSTEM PEDICLE SCREW MUST MC SCREW Ø 6.5X40 CANNULATED NKB MEDACTA INTERNATIONAL SA 03.58.254 2321448 07630971293663

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Required Intervention