Anteralign Spinal System with Titan nanoLock Surface technology 46261055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000128494), received between Mar 13, 2023 and Sep 16, 2024 — classified as 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH ANTERAL IGN CAGE HAVING SPINAL THERAPY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT CAGE WAS MISALIGNED, HALF COMING OFF AND SO BONE FUSION COULD NOT BE ACHIEVED. THE INITIAL CASE, WHICH WAS CHANGED FROM DD (CLYDESDALE PTC) TO AG (ANTERALIGN TL), WAS USED IN THE SAME WAY AS WHEN USING DD. THE OPERATION WAS COMPLETED WHEN THE LEFT SIDE WAS SLIGHTLY REMOVED DURING THE INITIAL STAGE USING AG WITH L1-2. AN X-RAY CONFIRMED THAT THE HALF OF THE CAGE WAS REMOVED. DD WAS USED PREVIOUSLY AND IT WAS OVERRUN, SO IT WAS SWITCHED TO AG, BUT THE AG HAS ALSO FALLEN OUT. PATIENT'S SYMPTOMS IMPROVED AND THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO PLAN FOR THE REVISION SURGERY AT THIS TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20223623 ↗
• InjuryApr 26, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN AN L4/5 OLIF FOR L4/5 SPONDYLOLISTHESIS. IT WAS REPORTED THAT THE CAGE BACKED OUT. THE PATIENT HAD SYMPTOMS IN LOWER LIMBS AND LOWER BACK PAIN. THE HCP STATED THAT THE PATIENT HAD DISABILITY DUE TO THE EVENT, PATIENT'S SYMPTOMS, AND COMPLICATIONS. THE PATIENT WAS UNABLE TO ACHIEVE BONE FUSION. NO REOPERATION WAS SCHEDULED AT THIS TIME AND THE POSTERIOR FUSION WAS PERFORMED ON THE SAME DAY. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Inadequate Osseointegration; Insufficient Information; Pain

  MAUDE report 16816152 ↗
• MalfunctionMar 13, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A SPACER USED IN SPINAL THERAPY FOR L4 VERTEBRAL BODY COMPRESSION. LEVELS IMPLANTED: L4/5 IT WAS REPORTED THAT THE SURGERY WAS PERFORMED THREE TIMES. IT WAS DEPLOYED TO THE CAUDAL SIDE FOR PATIENTS WITH TH7-L4 FIXATION. FIRST OF ALL, OLIF WAS DEPLOYED TO L4/5, THEN THE REAR PART WAS DEPLOYED TO L4-S2. BKP TO L4. CY WAS USED FOR 5/S. EVERYTHING WAS COMPLETED, AND WHEN THE POSTOPERATIVE X-RAY WAS CHECKED, IT WAS DISCOVERED THAT THE AG WAS BACK OUT. THIS WAS A REPEAT SURGERY FOR L4 VERTEBRAL BODY COMPRESSION. THE DATES OF THE PREVIOUS SURGERIES WERE (B)(6) 2018, (B)(6) 2019 AND (B)(6) 2020. THE INITIAL SURGERY WAS TH7-L4 FIXATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16527300 ↗