BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM SURGICAL

    MDR report key: 24571787 · Received March 11, 2026

    Report

    Report Number
    1421101-2026-00002
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    January 6, 2026
    Report Date
    March 9, 2026
    Manufacturer
    AVALIGN TECHNOLOGIES INC.
    Product Code
    GEN
    UDI-DI
    00190776341381
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DURING A MAKO ASSISTED LEFT TOTAL HIP CASE, THE LEWIN CLAMP BROKE. THE SURGEON INSPECTED THE INSTRUMENT AND THE PATIENT; THE SCRUB TECH AND CIRCULATOR INSPECTED THE EQUIPMENT. SPD WAS CONTACTED TO COME AND INSPECT THE INSTRUMENT; ALL PARTIES INVOLVE AGREE THAT ALL PARTS OF THE INSTRUMENT WERE OBTAINED AND ACCOUNTED FOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627394 MILLENNIUM SURGICAL LEWIN BONE FORCEPS GEN AVALIGN TECHNOLOGIES INC. 0-47130 00190776341381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other