Anteralign Spinal System with Titan nanoLock Surface technology 46221045Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000128777), received between Oct 5, 2023 and Oct 14, 2024 — classified as 2 injuries.

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.

• InjuryOct 14, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A L2/3 STAND-ALONE OLIF WITH PIVOX PLATE IN A PATIENT WHO HAD PREVIOUS SURGERY FROM L3-PELVIS WITH SCREWS AND INTERBODIES. LEVELS IMPLANTED WERE L2/3. IT WAS REPORTED THAT THE ANTERALIGN TS CAGE SPIT OUT TO THE SIDE OF L2/3 WHERE THE IMPLANT WAS PLACED. REVISION SURGERY INCLUDED REMOVAL OF ANTERALIGN AND PIVOX PLATE THAT WAS ATTACHED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. THE SPACER WAS REPLACED BY A CLYDESDALE PTC IMPLANT AND EXTENDED THE PATIENT'S PSF LEVELS UP TO L2.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20437768 ↗
• InjuryOct 5, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR DEGENERATION. PROCEDURE PERFORMED WAS OLIF3 (INTERVERTEBRAL). LEVEL AT WHICH IMPLANT PERFORMED WAS L3/4. IT WAS REPORTED THAT THE L3/4 OLIF CAGE BACKED OUT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY IN THE OVERALL PROCEDURE TIME OF GREATER THAN 60 MINUTES. ADDITIONAL SURGERY WAS PERFORMED AS A RESULT OF THIS EVENT THAT WAS ADDITIONAL IMPLANT INSERTION WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17883225 ↗