Anteralign Spinal System with Titan nanoLock Surface technology 46261255Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000128548), received between Mar 8, 2024 and Jan 5, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Mechanical 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.

Most reported problems

Recent adverse event reports

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

• MalfunctionJan 5, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING OBLIQUE LATERAL INTERBODY FUSION AT LEVELS L3/4, 4/5 FOR SPINAL CANAL STENOSIS. IT WAS REPORTED THAT CAGE WAS PLACED ANTERIORLY DURING THE L4/5 OLIF. AT THAT TIME, THERE WAS A CAGE IN FRONT OF THE BODY FROM THE ANTERIOR SURFACE OF THE VERTEBRAL BODY. WHEN RE-INSERTION WAS ATTEMPTED, LOOSENING WAS CONFIRMED. IT WAS REPLACED WITH 14 MM, HOWEVER, SLIGHT LOOSENESS WAS A CONCERN. IT WAS DETERMINED THAT THERE WERE NO PROBLEMS IF COMPRESSION WAS APPLIED IN THE BACK BECAUSE THE BONE SPUR WAS STRONG, AND THE ANTERALIGN PLATE/SCREW COULD NOT BE USED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21075841 ↗
• InjuryMar 8, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A CAGE IN AN UNKNOWN SPINAL THERAPY DUE TO LEG PAIN. IT WAS REPORTED THAT THE CAGE WAS IMPLANTED AS A STAND ALONE DEVICE WITH A LATERAL PLATE AT THE LEVEL ABOVE A PREVIOUS ONE LEVEL FUSION. THE CAGE MIGRATED POST INITIAL SURGERY COMPLETION. THE PATIENT STARTED EXPERIENCING LEG PAIN POST SURGERY (WHICH WAS RESOLVED UPON EXPLANT AND IMPLANTATION OF NEW PRODUCT). UPON BRINGING THE PATIENT BACK AND HAVING A CT PERFORMED, IT WAS DISCOVERED THAT THE CAGE HAD MIGRATED AND NOT ONLY BACKED OUT BUT ALSO HAD ROTATED. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain

  MAUDE report 18863150 ↗