BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW PEDICLE SCREW 7X45

    MDR report key: 15390881 · Received September 9, 2022

    Report

    Report Number
    3005180920-2022-00680
    Event Type
    Injury
    Date Received
    September 9, 2022
    Date of Event
    August 8, 2022
    Report Date
    October 11, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834295
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 6 SEP 2022. LOT 2022278: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2020. EXPIRATION DATE: 2025-SEP-23. 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 ITEMS REPORTED IN THIS COMPLAINT). ADDITIONAL IMPLANTED COMPONENTS. BATCH REVIEW PERFORMED ON 6 SEP 2022 ON PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45 (K121115) LOT 1923134: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-OCT-2019. EXPIRATION DATE: 2024-OCT-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. BATCH REVIEW PERFORMED ON 6 SEP 2022 ON PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45 (K121115) LOT 2021798: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUL-2020. EXPIRATION DATE: 2025-JUL-16. 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. BATCH REVIEW PERFORMED ON 6 SEP 2022 ON PEDICLE SCREW 03.50.031 PEDICLE SCREW 7X45 (K121115) LOT 2022667: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2020. EXPIRATION DATE: 2025-OCT-07. 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 ITEMS REPORTED IN THIS COMPLAINT).

    Additional Manufacturer Narrative · 0

    DATE OF MANUFACTURER ALERTED CORRECTED WITH 8 AUGUST 2022. THE INITIAL EMDR RESULTS TO BE SENT WITH 1 DAY OF DELAY BECAUSE THE AWARENESS DATE REPORTED WAS NOT CORRECT.

    Description of Event or Problem · 0

    ABOUT 1 YEAR AND 6 MONTHS AFTER THE PRIMARY SURGERY, A REVISION SURGERY WAS PERFORMED DUE TO L3/4/5 SCREWS LOOSENING AND L4/5 NOT FUSION. IT IS UNKNOWN WHICH SCREW CAME LOOSE. THE L3-5 SCREW WAS REMOVED TO REPLACE THE CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307453 PEDICLE SCREW PEDICLE SCREW 7X45 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 03.50.031 2022278 07630030834295

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention