Anteralign Spinal System with Titan nanoLock Surface technology 46821214Recalls & reported problems
Medtronic Sofamor Danek, Inc. · TRIAL 46821214 MD 12DG 32X25X14MM · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000147495), received between Jun 10, 2026 and Jun 10, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Use of Device Problem” (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
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2026Use of Device Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICES WERE CROSS THREADED. THERE WAS NO PATIENT INVOLVED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT OCCURRED ON THE BACK TABLE WHILE SETTING UP BEFORE THE PATIENT WAS EVEN INSIDE THE OPERATING ROOM. THIS WAS A WEAR AND TEAR PROBLEM THAT HAD NOTHING TO DO WITH THE PATIENT OR ANYONE ELSE OTHER MEDICAL PERSONNEL. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS PRODUCT COMPLAINT WAS FOUND TO BE A USER ERROR. IT WAS LATER DISCOVERED THAT THE INSERTER WAS NOT PROPERLY INSERTED INTO THE TRIAL IMPLANT THEREFORE THERE WAS NO ACTUAL WEAR AND TEAR PROBLEM TO BE RESOLVED WITH THIS PRODUCT .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25453421 ↗
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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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