BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿

    MDR report key: 25199347 · Received May 18, 2026

    Report

    Report Number
    3003120897-2026-00902
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 18, 2026
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    MAX
    UDI-DI
    00763000572181
    PMA / PMN Number
    K212524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PART # 4680005; LOT # K23J1108 VISUAL AND OPTICAL INSPECTION CONFIRMED THE THREADED TIP OF THE TRIAL SHAFT HAS BROKEN. THE DAMAGE TO THE INSTRUMENT IS CONSISTENT WITH OVERLOAD. 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, HEALTHCARE PROVIDER) REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE STRIPPED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURED ON THE BACK TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123917 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK USA, INC. 4680005 K23J1108 00763000572181

    Patients

    Seq Age Sex Outcome Treatment
    1