BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEXUS SPINE

    MDR report key: 24573201 · Received March 11, 2026

    Report

    Report Number
    3011390763-2026-00001
    Event Type
    Injury
    Date Received
    March 11, 2026
    Date of Event
    February 9, 2026
    Report Date
    March 11, 2026
    Manufacturer
    NEXUS SPINE, LLC
    Product Code
    OVD
    PMA / PMN Number
    K243934
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RADIOGRAPHS PROVIDED TO THE COMPANY CONFIRMED THE REPORTED EVENT. REVIEW OF RADIOGRAPHS IDENTIFIED THAT THE DEVICES WERE USED IN THIS PATIENT FOR INTERBODY FUSION AT THREE ADJACENT LEVELS WHERE A CAUDAL SCREW AT L4 - L5 HAS BEGUN TO BACK OUT AND THE SCREW HAS PUSHED PAST THE PLATE (THERE IS A GENESIS PLATE AND SCREWS JUST BELOW THE LEVEL L5-S1 - THESE WERE NOT INVOLVED IN THE REPORTED EVENT, AND WERE PROPERLY USED AS SUPPLEMENTAL FIXATION) THE SURGEON ONLY USED SUPPLEMENTAL FIXATION ON ONE LEVEL (COMPANY IMPLANTS ARE INDICATED TO USE SUPPLEMENTAL FIXATION AT MORE THAN TWO LEVELS). A COMPANY REPRESENTATIVE DISCUSSED THE OFF-LABEL USE OF THE SYSTEM WITH THE USER. A COMPANY REPRESENTATIVE RECEIVED A CALL FROM THE SURGEON THAT THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2026, TO EXPLANT A SCREW AND COVER PLATE. THE SURGEON DECIDED TO REMOVE THE SCREW AND COVER PLATE BECAUSE THE SEGMENT HAD FUSED, THEREFORE ONLY ONE OF THE SCREWS AND ONE COVER PLATE HARDWARE WERE REMOVED. PER THE COMPANY IFU, "AFTER THE SPINAL FUSION IS COMPLETE, THE SURGEON MUST CONSIDER REMOVING THE SUPPLEMENTAL FIXATION, AS THE SUPPLEMENTAL FIXATION SERVES NO FUNCTIONAL PURPOSE AFTER COMPLETE SPINAL FUSION." DEPENDING ON THE PATIENT, SPINAL HARDWARE REMOVAL MAY BE PART OF THE SURGERY AND IS COMMON PRACTICE IN THE INDUSTRY. THE EXPLANTED DEVICES WERE REQUESTED TO BE RETURNED TO THE COMPANY FOR INVESTIGATION, BUT UPON FURTHER REQUESTS IT WAS DETERMINED THAT THE HARDWARE WAS DISPOSED OF AT THE HOSPITAL; THEREFORE, NO FURTHER INVESTIGATION COULD BE PERFORMED. DEVICE REVIEW: THE PART NUMBERS AND LOT NUMBERS OF THE DEVICES USED IN THE CASE WERE IDENTIFIED BASED ON THE SURGERY INFORMATION AND CASE RECORDS, WHICH IS ONE OF THE 6 SCREW, AND ONE OF THE 3 COVER PLATE PART NUMBER/LOT NUMBER COMBINATIONS USED IN THIS PATIENT'S SURGICAL PROCEDURE IDENTIFIED BELOW: SYSTEM: PART DESCRIPTION: PART NO. UDI-DI NO. LOT NO. T. QTY PER PART STABLE-L, DL SCREW, SMOOTH, 4.9X24MM, 525145, (B)(4), 120301, (4), STABLE-L, DL SCREW, SMOOTH, 4.9X24MM, 525145, (B)(4), 195935, STABLE-L, DL SCREW, SMOOTH, 4.9X24MM, 525145, (B)(4), A444-02, STABLE-L, DL SCREW, SMOOTH, 4.9X24MM, 525145, (B)(4), B975-01, STABLE-L, DL SCREW, SMOOTH, 4.9X27MM, 525146, (B)(4), A508-02, (4), STABLE-L, DL SCREW, SMOOTH, 4.9X27MM, 525146, (B)(4), B674-02, STABLE-L, 12MM STABLE-L, COVER PLATE, 525212, (B)(4), 102001, (4), STABLE-L, 12MM STABLE-L, COVER PLATE, 525212, (B)(4), 1754-01, STABLE-L, 12MM STABLE-L, COVER PLATE, 525212, (B)(4), 672-02, DHR REVIEW SUMMARY: NO MATERIAL NON-CONFORMANCE'S, NO MANUFACTURING ERRORS, NOR DISCREPANCIES WITH RESPECT TO MATERIAL TYPE, TREATMENTS, DIMENSIONS THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. PARTS MET ACCEPTANCE CRITERIA UPON RELEASE.

    Description of Event or Problem · 0

    PATIENT HOSPITALIZED FOR REMOVAL OF ONE OF THE SCREWS AND ONE OF THE COVER PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135652 NEXUS SPINE INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION OVD NEXUS SPINE, LLC 525145 120301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other