BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS

    MDR report key: 25005646 · Received April 27, 2026

    Report

    Report Number
    2027467-2026-00071
    Event Type
    Injury
    Date Received
    April 27, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 27, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    NKB
    PMA / PMN Number
    K181677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPLANT HAS NOT RETURNED FOR EVALUATION. REVISION SURGERY IS PLANNED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. 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 INFORMATION AS AVAILABLE. ANY FIELD 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

    DURING 1-YEAR POSTOPERATIVE FOLLOW-UP VISIT, RADIOGRAPH IMAGING REVEALED A SCREW SHANK FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378863 INVICTUS THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention