BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 21252031 · Received January 28, 2025

    Report

    Report Number
    21252031
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 5, 2024
    Report Date
    January 16, 2025
    Manufacturer
    MISONIX, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    THE PROCEDURE DONE TO THE PATIENT WAS POSTERIOR LUMBAR LAMINECTOMY. MISONIX NEXUS BONESCALPEL WAS USED DURING THE PROCEDURE. TWO HOURS IN TO THE PROCEDURE, SCRUB TECH NOTICED THAT THE BONE SCALPEL TIP WAS CHARRED AND BENT. I OPENED A NEW NEXUS BONESCALPEL SUPPLY. SPINE COORDINATOR CALLED AND INFORMED ABOUT WHAT HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606414 NEXUS INSTRUMENT, ULTRASONIC SURGICAL LFL MISONIX, INC. 110-31-1125 243188

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown