Anteralign Spinal System with Titan nanoLock Surface technology 46321455Recalls & reported problems
Medtronic Sofamor Danek, Inc. · NANO SPACER 46321455 TI 12DG 23W 14X55MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000127343), received between Jun 29, 2023 and Jun 29, 2023 — classified as 1 injury.
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.
Most reported problems
Device problems
- Migration1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 29, 2023Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH LATERAL DECOMPRES SION THERAPY. IT WAS REPORTED THAT THE CAGE MIGRATED LATERALLY RESULTING IN A FOLLOW UP SURGERY TO PUT A PLATE ON THE CAGE AND REPOSITION. THE INITIAL SURGERY WAS NOT A REVISION, BUT THE MIGRATION RESULTED IN REVISING THE LOOSE CAGE. SURGEON DECIDED THE CAGE MIGRATED BECAUSE THE ALL WAS RUPTURED. NO COMPLICATIONS AS OF YET FROM THE RE-OP. INITIAL COMPLICATION BEFORE REPOSITIONING THE CAGE WAS SEVERE PAIN.
Patient problems: Pain
MAUDE report 17234797 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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