BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 19312511 · Received May 14, 2024

    Report

    Report Number
    3009540749-2024-00009
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 10, 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 FIRST-STAGE SURGERY WITH INCORE LAPIDUS SYSTEM WAS PERFORMED (B)(6) 2024. AFTER 2 WEEKS ON (B)(6) WHEN SECOND-STAGE SURGERY TO SHORTEN THE METATARSUS WAS PERFORMED, DURING THE SURGERY THE SURGEON FOUND THAT THE INCORE'S SCREW ON THE BOTTOM SIDE WAS FRACTURED. AFTER THE INITIAL SURGERY, THE PATIENT WAS FITTED WITH AN UNLOADING BRACE ON THE BIG TOE. HOWEVER, THE SCREW APPEARED TO BE BROKEN OFF. RE-OPERATION IS BEING PLANNED, BUT NO DATE HAS BEEN SET AND THE NATURE OF THE SURGERY IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635150 INCORE LAPIDUS SYSTEM SCREW HWC MEDARTIS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown