BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 10390826 · Received August 11, 2020

    Report

    Report Number
    3009540749-2020-00023
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    July 13, 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 A LATER DATE, THE SURGEON FOUND THAT ONE OF THE SCREWS HAD BROKEN AT THE TIPS INSIDE THE MEDIAL CUNEIFORM. THE IMPLANT WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854149 INCORE LAPIDUS SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention