BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 23830441 · Received December 17, 2025

    Report

    Report Number
    2027467-2025-00263
    Event Type
    Malfunction
    Date Received
    December 17, 2025
    Date of Event
    December 1, 2025
    Report Date
    December 17, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HXX
    UDI-DI
    00190376419121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER HAS NOT RETURNED FOR EVALUATION. PHOTOGRAPHS WERE NOT PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE IDENTIFYING LOT NUMBER WAS NOT PROVIDED. BASED ON THE INFORMATION PROVIDED, THE ROOT CAUSE COULD NOT BE DETERMINED. ALPHATEC SPINE IS SUBMITTING THIS REPORT TO COMPLY WITH THE FDA REGULATIONS 21 CFR 803. ALPHATEC SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS AVAILABLE. ANY FIELD THAT IS LEFT BLANK WAS NOT KNOWN AT THE TIME OF THIS SUBMISSION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIP OF THE DRIVER BROKE OFF DURING A CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2041180 INVICTUS SPINAL FIXATION SYSTEM SCREWDRIVER HXX ALPHATEC SPINE, INC. 17830 00190376419121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown