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Anteralign Spinal System with Titan nanoLock Surface technology 46261450Recalls & reported problems

Medtronic Sofamor Danek, Inc. · NANO SPACER 46261450 6DG 20W 14X11.9X50 · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000128586), received between Oct 3, 2023 and Dec 16, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Migration1

Patient problems

  • Bone Fracture(s)1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 16, 2025Migration; Migration

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A D LIF L3-L4 PROCEDURE IN A PATIENT. IT WAS REPORTED THAT THE CAGE MIGRATED LATERALLY POSTOPERATIVELY. THE SURGEON ATTEMPTED TO CUT THE IMPLANT IN HALF AND ATTEMPT TO TAMP THE CAGE INTO A MORE APPROPRIATE POSITION. HE THEN EXTENDED THE LEVELS OF POSTERIOR INSTRUMENTATION. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23816158 ↗
  • InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE DEGREE OF LORDOSIS CAUSED A FRACTURE IN THE VERTEBRAL BODY. FRACTURED VERTEBRAL BODY AT THE ADJACENT LEVEL.

    Patient problems: Bone Fracture(s)

    MAUDE report 17858406 ↗

Other Intervertebral fusion device with integrated fixation, lumbar devices

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Sources and updates

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