BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARX SAI

    MDR report key: 24816955 · Received April 8, 2026

    Report

    Report Number
    3004499989-2026-00016
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 8, 2026
    Manufacturer
    LIFE SPINE
    Product Code
    NKB
    UDI-DI
    00190837175214
    PMA / PMN Number
    K241464
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DESCRIPTION OF THE REPORTED EVENT, NO DEVICE FAILURE OCCURED. THE SCREW USES THE IDENTICAL HEAD AS THE OTHER IMPLANTED SCREW AND PROVIDES A EQUIVALENT CONE OF ANGULATION. DURING THE PROCEDURE, THE SURGEON EXPERIENCED DIFFICULTY ALIGNING THE ROD WITHIN THE FULL CONSTRUCT TO CONNECT WITH THE ANCHORING SCREWS. AS A RESULT, THE SCREWS WERE REMOVED AND REPLACED WITH ANOTHER SCREW FROM THE SAME FAMILY.

    Description of Event or Problem · 0

    IT WAS STATED THAT THE DR. WAS HAVING A VERY DIFFICULT TIME LINING UP THE ROD TO ALL OF THE TULIP HEADS AND EVERYTHING WOULD BE ALIGNED BUT TWO SCREWS,EXPLANTED THE TWO SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876090 ARX SAI SCREW NKB LIFE SPINE 18-8590-09 00190837175214

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention