BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 10390919 · Received August 11, 2020

    Report

    Report Number
    3009540749-2020-00024
    Event Type
    Injury
    Date Received
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS OBTAINED WHICH CHANGES THE OUTCOME OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH THE INCORE LAPIDUS SYSTEM AT AN UNKNOWN DATE. AT A LATER DATE, WHICH IS UNKNOWN THE IMPLANT WAS REMOVED DUE TO BROKEN SCREW. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    856194 INCORE LAPIDUS SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention