BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS OCT SPINAL FIXATION SYSTEM

    MDR report key: 25137139 · Received May 11, 2026

    Report

    Report Number
    2027467-2026-00088
    Event Type
    Malfunction
    Date Received
    May 11, 2026
    Date of Event
    April 13, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HWX
    UDI-DI
    00190376301518
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE TAP 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. IF ADDITIONAL INFORMATION IS PROVIDED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TAP BROKE DURING SCREW PREPARATION. THE TIP WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528850 INVICTUS OCT SPINAL FIXATION SYSTEM TAP, BONE HWX ALPHATEC SPINE, INC. 19807-30 00190376301518

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown