BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 24566271 · Received March 11, 2026

    Report

    Report Number
    3003120897-2026-00403
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    April 18, 2025
    Report Date
    March 11, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    UDI-DI
    00763000572174
    PMA / PMN Number
    K212524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART# 4680004, LOT# K23F1290 VISUAL AND FUNCTIONAL TESTING IDENTIFIED THAT THE INNER SHAFT OF THE INSTRUMENT IS MISSING. THE INSTRUMENT CANNOT FUNCTION AS INTENDED. THIS REGULATORY REPORT IS BEING SUBMITTED DUE TO RETROSPECTIVE REVIEW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WOULD NO LONGER THREAD INTO THE DEVICE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628297 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. 4680004 K23F1290 00763000572174

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown