BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿

    MDR report key: 24586269 · Received March 12, 2026

    Report

    Report Number
    3003120897-2026-00468
    Event Type
    Malfunction
    Date Received
    March 12, 2026
    Date of Event
    August 6, 2025
    Report Date
    March 12, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    UDI-DI
    00763000193942
    PMA / PMN Number
    K212524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS PART# 4680005 LOT# K23J1108 VISUAL AND OPTICAL EXAMINATION IDENTIFIED THAT THE THREADS OF THE INTERBODY HANDLE HAVE BEEN BROKEN OFF AND JAMMED/STUCK IN THE TRIAL. THIS IS CONSISTENT WITH OVER-TORQUE. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER TRAIL USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A LATERAL APPROACH SPINE FUSION, THE TIP OF THE INSERTER BROKE OFF IN THE TRIAL, RENDERING BOTH THE TRIAL AND INSERTER UNUSABLE DURING THE CASE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2025-AUG-08 E1 (REP): ADDITIONAL INFORMATION RECEIVED THAT PROCEDURE INVOLVED WAS DIRECT LATERAL INTERBODY FUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126307 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. 4680005 K23J1108 00763000193942

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female