BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPDIUS SYSTEM

    MDR report key: 19286482 · Received May 10, 2024

    Report

    Report Number
    3009540749-2024-00002
    Event Type
    Injury
    Date Received
    May 10, 2024
    Date of Event
    March 29, 2024
    Report Date
    May 10, 2024
    Manufacturer
    MEDARTIS INC.
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE OUTCOME OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL IMPLANTATION OF THE INCORE LAPIDUS SYSTEM ON (B)(6) 2023. AFTER 11 MONTHS FROM THE INTIAL, THE SURGEON FOUND THAT THE SCREW OF THE INNER SIDE WAS FRACTURED. THEN REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AND ALL IMPLANTS THAT WERE IMPLANTED AT INITIAL WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308822 INCORE LAPDIUS SYSTEM SCREW HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown