BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INVICTUS SPINAL FIXATION SYSTEM

    MDR report key: 25094360 · Received May 6, 2026

    Report

    Report Number
    2027467-2026-00084
    Event Type
    Malfunction
    Date Received
    May 6, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 6, 2026
    Manufacturer
    ALPHATEC SPINE, INC.
    Product Code
    OLO
    UDI-DI
    00190376475202
    PMA / PMN Number
    K153603
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DRIVER WAS RETURNED TO ALPHATEC AND IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    CORRECTION: H3. YES. H6. TYPE OF INVESTIGATION: 10, 3331. INVESTIGATION FINDINGS: 3252. INVESTIGATION CONCLUSIONS: 61. H8. USAGE OF DEVICE: REUSE. DEVICE EVALUATION: VISUAL INSPECTION CONFIRMS THE EVENT. THE DISTAL END OF THE HEXALOBE TIP HAS SHEARED OFF OF THE DRIVER. THE ROOT CAUSE IS LIKELY EXCESSIVE/ECCENTRIC LOADING ON THE TIP OF THE DRIVER, LIKELY SEEN FROM INSERTING OR REMOVING A SCREW AND/OR FAILURE TO FULLY SEAT THE DRIVER INTO THE FEMALE HEX PRIOR TO DRIVING. REVIEW OF DEVICE HISTORY RECORDS SHOWED NO MANUFACTURING OR PROCESSING RELATED IRREGULARITIES THAT WOULD CAUSE OR CONTRIBUTE TO THIS FAILURE MODE. LABELING REVIEW: WARNINGS/CAUTIONS/PRECAUTIONS: RISKS IDENTIFIED WITH THE USE OF THESE DEVICES, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE DEVICE COMPONENT FAILURE, LOSS OF FIXATION/STABILIZATION, NON-UNION, VERTEBRAL FRACTURE, NEUROLOGICAL INJURY, VASCULAR OR VISCERAL INJURY. POSSIBLE ADVERSE EFFECTS: INITIAL OR DELAYED LOOSENING, DISASSEMBLY, BENDING, DISLOCATION, AND/OR BREAKAGE OF DEVICE COMPONENTS.

    Description of Event or Problem · 0

    THE TIP OF THE SCREWDRIVER WAS BROKEN OFF WHILE ATTEMPTING TO ADJUST A SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470550 INVICTUS SPINAL FIXATION SYSTEM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ALPHATEC SPINE, INC. 17950-N EM59056 00190376475202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown