BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 9917006 · Received April 2, 2020

    Report

    Report Number
    3009540749-2020-00013
    Event Type
    Injury
    Date Received
    April 2, 2020
    Report Date
    April 2, 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 AN INCORE LAPIDUS SYSTEM ON AN UNKNOWN DATE. AT A LATER UNKNOWN DATE AND FOR REASONS NOT REPORTED THE INCORE LAPIDUS POST WAS REMOVED FROM PATIENT. NO PATIENT COMPLICATIONS FROM REMOVAL SURGERY WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379053 INCORE LAPIDUS SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other