BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 21274184 · Received January 30, 2025

    Report

    Report Number
    2027467-2025-00001
    Event Type
    Injury
    Date Received
    January 30, 2025
    Date of Event
    January 7, 2025
    Report Date
    January 30, 2025
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    NKB
    UDI-DI
    00190376404752
    PMA / PMN Number
    K214006
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANT 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. 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 A SCREW BROKE AND NEEDED TO BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590437 INVICTUS SPINAL FIXATION SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM NKB ALPHATEC SPINE, INC. 55005-105-090 00190376404752

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention