BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY

    MDR report key: 24480402 · Received March 2, 2026

    Report

    Report Number
    3003120897-2026-00324
    Event Type
    Malfunction
    Date Received
    March 2, 2026
    Date of Event
    January 28, 2026
    Report Date
    April 8, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    UDI-DI
    00763000193935
    PMA / PMN Number
    K212524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PRODUCT#: 4680004, LOT#: K24K1166 VISUAL EXAMINATION IDENTIFIED THE THREADS WERE DAMAGED FROM THE ATTACHMENT PROCESS. 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.

    Additional Manufacturer Narrative · 0

    E: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. 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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INNER SHAFT OF THE DEVICE WOULD NOT ADVANCE THROUGH THE INSERTER. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2618 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ SURFACE TECHNOLOGY INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. 4680004 K24K1166 00763000193935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown