BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 24561094 · Received March 10, 2026

    Report

    Report Number
    2027467-2026-00040
    Event Type
    Malfunction
    Date Received
    March 10, 2026
    Date of Event
    February 10, 2026
    Report Date
    March 10, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    HWX
    UDI-DI
    00190376192079
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES. 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 HAS A BROKEN TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621934 INVICTUS SPINAL FIXATION SYSTEM TAP, BONE HWX ALPHATEC SPINE, INC. 17109-055 8289906 00190376192079

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown