BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM

    MDR report key: 17389620 · Received July 25, 2023

    Report

    Report Number
    3005180920-2023-00540
    Event Type
    Injury
    Date Received
    July 25, 2023
    Date of Event
    June 26, 2023
    Report Date
    July 25, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857461
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON (B)(6), 2023: LOT 2020775: (B)(4), MANUFACTURED AND RELEASED ON 25-MAY-2020. EXPIRATION DATE: 2025-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4), OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. ADDITIONAL INVOLVED IMPLANT: BATCH REVIEW PERFORMED ON (B)(6), 2023 ON PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM (K141988) LOT. 2125837 LOT 2125837: (B)(4), MANUFACTURED AND RELEASED ON 16-NOV-2021. EXPIRATION DATE: 2016-10-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4), OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    2 PEDICLE CANNULATED SCREWS WERE FOUND LOOSE DURING REVISION SURGERY FOR PATIENT'S BACK PAIN (10 MONTHS POST PRIMARY). LEVEL L4-L5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194379 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 5X40MM SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2020775 07630030857461

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention