BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT, REUSABLE

    MDR report key: 10384553 · Received August 10, 2020

    Report

    Report Number
    3009540749-2020-00022
    Event Type
    Malfunction
    Date Received
    August 10, 2020
    Date of Event
    July 10, 2020
    Report Date
    August 10, 2020
    Manufacturer
    NEXTREMITY SOLUTIONS
    Product Code
    LXI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A SURGERY ON (B)(6) 2020 THE INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT FROZE. THE SURGERY WAS DELAYED FOR ABOUT AN HOUR. SURGERY WAS COMPLETED USING ANOTHER SYSTEM. PATIENT OUTCOME WAS REPORTED AS GOOD AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853240 INCORE LAPIDUS TARGETING GUIDE ASSEMBLY RIGHT, REUSABLE TARGETING GUIDE INSTRUMENT LXI NEXTREMITY SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR