Anteralign Spinal System with Titan nanoLock Surface technology 46261045Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000128470), received between Mar 2, 2023 and Dec 9, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH SPACER HAVING L2-L4 DIRECT LATERAL INTERBODY FUSION THERAPY. IT WAS REPORTED THAT THE INTERBODY HAD MIGRATED LATERALLY AND WAS NOTICED DURING POST OPERATIVE FOLLOW UP VISITS. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755038 ↗
• InjuryMar 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ADDITIONAL DRIVE FOR CAGE BACKOUT. IT WAS REPORTED THAT AFTER THE INITIAL OPERATION, IT WAS CONFIRMED VIA X-RAY THAT THE CAGE WAS DISLODGED TOWARDS THE ENTRY SIDE. EMERGENCY ANTERIOR SURGERY WAS ALSO PERFORMED DURING POSTERIOR FIXATION. THE CAGE WAS ABOUT 1 CM BACK IN 3 VERTEBRAE IN THE APPROACH DIRECTION. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. PROCEDURE PERFORMED IN INITIAL SURGERY WAS OBLIQUE LATERAL INTERBODY FUSION L2/3, (B)(6). THERE WAS NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21661490 ↗
• InjuryMar 9, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN L2-5 OLIF, AND REPLACED IN A POSTERIOR FIXATION FOR DEGENERATIVE SCOLIOSIS. IT WAS REPORTED THAT THE L3-4 CAGE WAS COMPLETELY DISLODGED AND HAD FALLEN OUT ON THE INGRESS SIDE. THE CAGE WAS REMOVED AND REPLACED WITHDD. THE REASON FOR THE DISLODGEMENT IS UNKNOWN. SINCE THE FIT WAS TIGHT DURING THE PROCEDURE, THE PHYSICIAN BELIEVED THAT THE PLATE/SCREW WAS REQUIRED FOR THE SECONDARY SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL L3-4 OLIF SURGERY, WITH AG EXTRACTION AND DD INSERTION WAS PERFORMED. THERE WAS A GREATER THAN 60 MINUTE DELAY IN OVERALL PROCEDURE TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16511527 ↗
• InjuryMar 2, 2023Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF L4/5 FOR S PONDYLOLISTHESIS. IT WAS REPORTED THAT FOR THE FIRST CASE OF THE NEW PATIENT, THE PHYSICIAN COMMENTED THAT IT IS NOT ABOUT THE INSTRUMENTS OR IMPLANTS; THE PATIENT WAS YOUNG AND HAD A STRONG INTERVERTEBRAL DISC; THE BLOOD VESSEL BRANCH WAS SLIGHTLY UPWARD; THE CAGE WAS DIAGONALLY INSERTED; AND A LARGE CAGE SIZE WAS SELECTED, WHICH COULD HAVE BEEN THE CAUSE. BECAUSE OF THE ABOVE REASONS, THE PATIENT DEVELOPED A HERNIA FROM THE CONTRALATERAL SIDE OF THE FORAMEN, AND THE SYMPTOMS WERE DEVELOPED DUE TO A SLIGHT NERVE ROOT COMPRESSION. ON (B)(6) 2023, DECOMPRESSION WAS ADDED FROM THE BACK. NERVOUS FORAMEN STENOSIS, ADDITIONAL DECOMPRESSION IS STATED IN THE MEDICAL RECORD. DURING THE POST-OPERATIVE SURGEON CONFIRMED THAT IT WAS NOT THAT IT WAS PRESSED WITH A CAGE AND THE PRESSURE WAS APPLIED. THERE WAS A SLIPPAGE, THE FACET WAS DEFORMED, AND THE SPINAL DISC WAS SWOLLEN AND COMPRESSED. FOR THE INTRAOPERATIVE MEP WAVEFORMS, THE WAVEFORMS WERE SMALL BEFORE THE OPERATION, BUT AFTER DECOMPRESSION, THE WAVEFORMS ALSO INCREASED AND IMPROVED.

  Patient problems: Hernia; Stenosis; Swelling/ Edema; Unspecified Nervous System Problem

  MAUDE report 16475815 ↗