BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 19312308 · Received May 14, 2024

    Report

    Report Number
    3009540749-2024-00005
    Event Type
    Injury
    Date Received
    May 14, 2024
    Report Date
    May 14, 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 INITIAL SURGERY WITH INCORE LAPIDUS SYSTEM WAS PERFORMED ON (B)(6) 2023. AFTER TWO MONTHS FROM THE INITIAL, THE SURGEON FOUND THAT THE SCREW ON THE BOTTOM SIDE WAS FRACTURED UNDER THE XRAYS. THE PATIENT WAS SUSPECTED OF HAVING A PSEUDOARTHRITIS AND HAS BEEN FOLLOWED UP TO DATE. THERE ARE NO PLANS FOR REOPERATION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576313 INCORE LAPIDUS SYSTEM SCREW HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown