BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 24433415 · Received February 24, 2026

    Report

    Report Number
    2027467-2026-00030
    Event Type
    Malfunction
    Date Received
    February 24, 2026
    Date of Event
    January 23, 2026
    Report Date
    February 24, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OLO
    UDI-DI
    00190376195902
    PMA / PMN Number
    K153603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229919 INVICTUS SPINAL FIXATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ALPHATEC SPINE, INC. 17140 00190376195902

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown