BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EUROSCREW TCP NG

    MDR report key: 20758680 · Received November 22, 2024

    Report

    Report Number
    9615788-2024-00001
    Event Type
    Injury
    Date Received
    November 22, 2024
    Date of Event
    March 26, 2024
    Report Date
    November 20, 2024
    Manufacturer
    TEKNIMED SAS
    Product Code
    MAI
    UDI-DI
    03760177042827
    PMA / PMN Number
    K230394
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A PATIENT OPERATED ON HER KNEE TIBIA FOR ACL SURGERY ON (B)(6) 2022 HAS COMPLAINED OF DISCOMFORT IN THE KNEE. AFTER CHECKING IT, TURNED OUT THAT THE SCREW INSTALLED AT THE TIME HAD BROKEN IN TWO WITH THE HEAD WHICH HAD GONE UP INTO THE KNEE (INTRA-ARTICULAR TIBIAL MIGRATION POST INITIAL SURGERY). AN ADDITIONAL SURGICAL INTERVENTION HAS BEEN PERFORMED TO EXTRACT THE SCREW ON (B)(6) 2024. AFTER THE ADDITIONAL SURGICAL INTERVENTION, THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2580291 EUROSCREW TCP NG BIODEGRADABLE BONE SCREW MAI TEKNIMED SAS 7320301 03760177042827

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Prefer Not To Disclose Other