Anteralign Spinal System with Titan nanoLock Surface technology 46221250Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000128838), received between Feb 7, 2023 and Jul 1, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Migration” (2 reports).

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.

• MalfunctionJul 1, 2026Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY ID: (B)(6) STAIL / (B)(6) STAIL IT WAS REPORTED THAT AT FOLLOW-UP IMAGING, THE PRINCIPAL INVESTIGATOR REVIEWED AP AND LATERAL STANDING SPINE X-RAYS AND OBSERVED THAT THE INTERBODY GRAFT HAD MOVED FROM ITS ORIGINAL PLACEMENT SITE. SPECIFICALLY, THE GRAFT HAD MIGRATED APPROXIMATELY 15 MM TOWARD THE LEFT LATERAL SIDE COMPARED WITH ITS INITIAL POSITION. WHEN THE INVESTIGATOR COMPARED THE CURRENT X-RAYS WITH EARLIER IMAGES FROM (B)(6) 2026, IT WAS NOTED THAT THE GRAFT HAD ALREADY BEGUN TO MIGRATE SLIGHTLY, INDICATING PROGRESSIVE MOVEMENT OVER TIME. UPDATE RECEIVED: DESCRIPTION HAS BEEN CHANGED TO MILD INTERBODY/CAGE MIGRATION AT L4¿L5. UPDATE RECEIVED: COMMENTS: IT WAS REPORTED THAT AT FOLLOW-UP IMAGING, THE PRINCIPAL INVESTIGATOR REVIEWED AP AND LATERAL STANDING SPINE X-RAYS AND OBSERVED THAT THE INTERBODY GRAFT HAD MOVED FROM ITS ORIGINAL PLACEMENT SITE. SPECIFICALLY, THE GRAFT HAD MIGRATED APPROXIMATELY 15 MM TOWARD THE LEFT LATERAL SIDE COMPARED WITH ITS INITIAL POSITION. WHEN THE INVESTIGATOR COMPARED THE CURRENT X-

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25674267 ↗
• MalfunctionFeb 7, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR LCS. PROCEDURE PERFORMED WAS ANTERIOR LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT THE 2 INTERVERTEBRAL OF L3 TO L5 OLIF WAS PERFORMED. AN X-RAY IMAGE WAS TAKEN IN PREPARATION FOR THE POSTERIOR FIXATION THE FOLLOWING WEEK WHERE IT WAS DISCOVERED THAT THE CAGE ON L3/4 WAS SLIGHTLY LESS THAN 5 MM BACK OUT IN THE DIRECTION OF THE APPROACH SIDE. THERE WAS NO FRAGMENT LEFT INSIDE THE PATIENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16310099 ↗