BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 6X50

    MDR report key: 18648848 · Received February 6, 2024

    Report

    Report Number
    3005180920-2024-00030
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    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 22 JANUARY 2024: LOT 2222870: (B)(4) MANUFACTURED AND RELEASED ON 10-MAY-2022. EXPIRATION DATE: 2027-APR-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE IMPLANTED SCREW WAS TOO CLOSE TO THE NERVE ROOT AND HAD TO BE REDIRECTED. THE SCREW WAS PLACED FREEHAND USING C-ARM. ABOUT 6 DAYS AFTER THE PRIMARY SURGERY, THE SURGEON REMOVED 6X50MM PEDICLE SCREW AND IMPLANTED A 7X50MM PEDICLE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463274 PEDICLE SCREW 6X50 SPINE PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 2222870

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention