Anteralign Spinal System with Titan nanoLock Surface technology 46260845Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000128425), received between Jan 18, 2023 and Oct 24, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 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.

• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF DUE TO LUMBAR SPONDYLOLISTHESIS. IT WAS REPORTED THAT WHEN INSERTING THE CAGE, THE ENDPLATE WAS BROKEN AND INSERTED. IT IS A TERMINAL PLATE DAMAGE CAUSED BY THE CAGE. AS A RESULT, AFTER THE CAGE WAS PLACED, ITS FIXATION WAS LOOSE AND IT MOVED, SO IT WAS REMOVED. CAGE ITSELF DID NOT HAVE A DEFECT. A REPLACEMENT CAGE OF APPROPRIATE SIZE WAS REINSTALLED.. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Bone Fracture(s)

  MAUDE report 20520630 ↗
• InjuryAug 14, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR DISC DEGENERATIVE DISEASE. PROCEDURE PERFORMED WAS PRONE OLIF THERAPY. LEVELS IMPLANTED L2-3-4-5. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT AN ANTERALIGN PLATE ON THE CAGE AT ANY OF THE 3 LEVELS, COULD NOT GET THE PLATE TO ENGAGE AND ATTACH TO THE CAGE L3-4 CAGE BACKED OUT AND WAS NOTICED ON (B)(6) NOTICED ON POST OP CT FOR MAZOR STAGE SURGERY ON (B)(6) ENDED UP REVISING INCISION AND REPOSITIONED CAGE THEN DID AN L2-S2 POSTERIOR FUSION THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 WITH 3 CAGES IMPLANTED AND 3 PLATES IMPLANTED AND EXPLANTED ON THIS DATE. ONE OF THE THREE CAGES HAD SHIFTED ON (B)(6) 2023. ON (B)(6) 2023, SECOND SURGERY WAS PERFORMED TO REPOSITION THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538754 ↗
• InjuryJul 5, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR ASD. PROCEDURE PERFORMED WAS TH10 TO IL POSTERIOR FIXATION + L2/3 ANTERIOR FIXATION. IT WAS REPORTED THAT THE 1 WEEK AFTER THE OLIF4 INTERVERTEBRAL, POSTERIOR FIXATION WAS PERFORMED, HOWEVER, IT WAS DISCOVERED THAT THE AG FOR L2/3 WAS BACKED OUT DURING THE POSTERIOR FIXATION. AFTER THE POSTERIOR FIXATION WAS COMPLETED, THE POSITION WAS REPLACED ON THE SAME DAY, THE AG WAS REMOVED FROM THE FRONT, AND THEN THE PLATE AND SCREW WERE ADDED TO THE AG AND PLACED AGAIN. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF MORE THAN 60 MINUTES IN OVERALL PROCEDURE TIME. PATIENT WAS NOT HOSPITALIZED OR STAYED LONGER. AN ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. AN ANTERIOR FIXATION WAS ADDED, WHICH WAS NOT PLANNED TO SWITCH THE POSITION AFTER POSTERIOR FIXATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253973 ↗
• InjuryJan 18, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR DEGENERATIVE SCOLIOSIS. PROCEDURE PERFORMED WAS OLIF. LEVEL AT WHICH THE IMPLANT WAS PERFORMED WAS L2/3/4/5. IT WAS REPORTED THAT THE CAGE BACKED OUT A BIT. OLIF WAS PERFORMED ON DECEMBER 19 AND POSTERIOR FIXATION WAS PERFORMED ON DECEMBER 26 FOR THE SECOND TIME AT THE SURGEON'S DISCRETION. SURGEON CONFIRMED THAT THE CAGE BETWEEN L2/3 THAT WAS PLACED LAST TIME WAS COMING OUT. THE REASON MAY BE DUE TO THE FACT THAT THE AG TRIAL DID NOT GO IN WELL, SO IT WAS CHANGED TO A DD TRIAL. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193252 ↗