BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW PEDICLE SCREW 5X40

    MDR report key: 18524978 · Received January 17, 2024

    Report

    Report Number
    3005180920-2023-01109
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    December 18, 2023
    Report Date
    January 17, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834141
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17 JANUARY 2024. LOT 157323: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JAN-2016. EXPIRATION DATE: 2020-12-02. 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 IMPLANTS INVOLVED. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.011 PEDICLE SCREW 5X40 (K121115) LOT. 1923854. LOT 1923854: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-FEB-2020. EXPIRATION DATE: 2025-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH THREE OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.011 PEDICLE SCREW 5X40 (K121115) LOT. 2020325 LOT 2020325: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MARCH-2020. EXPIRATION DATE: 2025-03-09. 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. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.013 PEDICLE SCREW 5X50 (K121115) LOT. 2020328. LOT 2020328: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-APR-2020. EXPIRATION DATE: 2025-03-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.018 PEDICLE SCREW 6X45 (K121115) LOT. 1820659. LOT 1820659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEP-2018. EXPIRATION DATE: 2023-09-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.018 PEDICLE SCREW 6X45 (K121115) LOT. 1821273. LOT 1821273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-JAN-2019. EXPIRATION DATE: 2023-12-16. 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. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.018 PEDICLE SCREW 6X45 (K121115) LOT. 1923861. LOT 1923861: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-FEB-2020. EXPIRATION DATE: 2025-02-09. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.457 BENT ROD TI 5.5X70MM (K121115) LOT. 2020532. LOT 2020532: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-JULY-2020. EXPIRATION DATE: 2025-06-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BATCH REVIEW PERFORMED ON 17 JANUARY 2024 ON PEDICLE SCREW 03.50.458 BENT ROD TI 5.5X75MM (K121115) LOT. 1821904. LOT 1821904: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-16. 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.

    Description of Event or Problem · 0

    AT ABOUT 3 YEARS 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON REVISED THE M.U.S.T SCREWS IN THE ORIGINAL CONSTRUCT AT L2 - L4, WITH M.U.S.T. MC SCREWS AND EXTENDED THE CONSTRUCT TO NOW INCLUDE L4 - L5. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817719 PEDICLE SCREW PEDICLE SCREW 5X40 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 157323 07630030834141

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention