BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCORE LAPIDUS SYSTEM

    MDR report key: 10406904 · Received August 14, 2020

    Report

    Report Number
    3009540749-2020-00028
    Event Type
    Malfunction
    Date Received
    August 14, 2020
    Report Date
    August 14, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    HWC
    PMA / PMN Number
    K180257
    Product Problem
    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

    IT WAS REPORTED A SURGERY OCCURED WITH THE INCORE LAPIDUS SINGLE USE SYSTEM ON AN UNKNOWN DATE. AT AN UNKNOWN POST OP DATE, THE SURGEON NOTED THE SCREW MISSED THE POST. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875895 INCORE LAPIDUS SYSTEM BONE SCREW HWC NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1