BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FACETFUSE

    MDR report key: 24971351 · Received April 23, 2026

    Report

    Report Number
    3005977257-2026-00001
    Event Type
    Malfunction
    Date Received
    April 23, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 23, 2026
    Manufacturer
    LESSPINE INNOVATIONS
    Product Code
    HXX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    INCIDENT (B)(6) 2026): WHILE FINAL TIGHTENING OF THE SECOND 5.0 X 35MM FACETFUSE RIGHT SIDE SCREW, THE A/O SHAFT BROKE APART AT THE PROXIMAL END WHERE THE A/O HANDLE ATTACHES TO THE TOP OF THE SHAFT. REMEDY: THE SEVERED TOP OF THE SHAFT WAS RECOVERED AND REMOVED FROM THE SURGICAL SITE. THE SURGEON WAS ABLE TO CONNECT THE HANDLE AND COMPLETE THE FINAL TIGHTENING TO THE FACET. THE INTERRUPTION TO THE CASE WAS BRIEF, THERE WAS NO HARM TO THE PATIENT. INSTRUMENT SHIPPED TO HEADQUARTERS ON MARCH 26TH, 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565059 FACETFUSE A/O CONNECT CONNECT CANNULATED SCREW DRIVER HXX LESSPINE INNOVATIONS 11-00037 LJ17

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention