Anteralign Spinal System with Titan nanoLock Surface technology 46501816Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000129859), received between Apr 1, 2025 and Apr 1, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCT USED IN L5/S OBLIQUE LATERAL INTERBODY FUSION (OLIF51) SPINAL THERAPY FOR L5/S LUMBAR CANAL STENOSIS (LCS). IT WAS REPORTED THAT WHEN THE OAR WAS INSERTED, THE TIP OF THE OAR'S NOZZLE PROTRUDED SIGNIFICANTLY BEYOND THE HOLE, CAUSING THE SCREW TO BECOME LOOSE. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. THE CAGE WAS PLACED BETWEEN THE VERTEBRAE AND A PILOT HOLE FOR THE FIRST SCREW WAS CREATED USING AN AWL AND IT FELT LIKE THE AWL PROTRUDED DEEPER THAN USUAL. FURTHERMORE, THE SCREW INSTALLED IN THAT PILOT HOLE WAS NOT EFFECTIVE AND WAS LOOSE, SO FELT SOMETHING UNUSUAL, SO REMOVED THE SCREW, AND THEN REMOVED THE CAGE. WHEN TESTED OUTSIDE THE SURGICAL FIELD, SIMILARLY NOTICED THAT THE AWL PROTRUDING DEEPER THAN NORMAL. A NEW CAGE WITH A ANOTHER LOT WAS OPENED, AND THE SAME AWL WAS USED, IT COULD BE INSTALLED WITHOUT ANY PROBLEMS (THE CAGE THAT WAS REMOVED THE FIRST TIME WAS USED FOR THE SCREW). THERE WERE NO PROBLEMS WERE CONFIRMED IN THE AWL ITSELF AND POOR SHAPE OF THE CAGE IS SUSPECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21736661 ↗