Anteralign Spinal System with Titan nanoLock Surface technology 46261260Recalls & reported problems
Medtronic Sofamor Danek, Inc. · NANO SPACER 46261260 T 6DG 20W 12X9.9X60 · 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 00763000128555), received between Nov 17, 2022 and Nov 17, 2022 — 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
- 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.
InjuryNov 17, 2022Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A CAGE-PLATE-SCREW CONSTRUCT IN AN OLIF FOR LEVELS 3-4 FOR ANOTHER MECHANICAL COMPLICATION. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS OLIF 3-5 ON (B)(6) 2022. THE 3-4 CAGE BACKED OUT. ON (B)(6) 2022, THEY REVISED BY PUSH IN THE CAGE AND ADDING THE INTEGRATED PLATE AND SCREW. ON PREVIOUS REVISION THE CAGE WAS INSPECTED AND NEW BIOLOGICAL GRAFT WAS USED. THE IMPLANT BACKED OUT PRIOR TO FUSION. ON (B)(6) 2022, THE PATIENT CAME TO CLINIC AND SHOWED THAT THE CAGE/PLATE/SCREW CONSTRUCT BACKED OUT. THE PRODUCTS WERE REPLACED WITH AN ALTERNATE DEVICE AND ADDITIONAL FIXATION. THE PATIENT IS ASYMPTOMATIC. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15813127 ↗
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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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