Anteralign Spinal System with Titan nanoLock Surface technology 46812212Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000193768), received between Jun 13, 2025 and Jun 13, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2025Use of Device Problem; Use of Device Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L2/3/4/5/ OLIF L5/S TLIF L2/S2AI PPS FIXED THERAPY FOR LUMBAR SPINAL STENOSIS, KYPHOSIS. IT WAS REPORTED THAT DURING THE L4/5 OLIF PROCEDURE, THE TRIAL SIZES WERE INCREASED FROM 6°8MM TO 12°10MM TO 12°12MM. WHEN INSERTING THE 12°12MM TRIAL, IT DID NOT ENTER THE INTERVERTEBRAL SPACE AND SLIPPED FORWARD, INSERTING TO THE OPPOSITE SIDE. THE TRIAL WAS QUICKLY WITHDRAWN, BUT THERE WAS BLEEDING. GAUZE WAS PACKED TO STOP THE BLEEDING, AND ONCE THE BLEEDING WAS SOMEWHAT CONTROLLED, A 12°11.50MM IMPLANT WAS INSERTED. SURGIFLO (A HEMOSTATIC AGENT) WAS THEN USED, FOLLOWED BY COMPRESSION WITH GAUZE TO STOP THE BLEEDING. AFTER THE BLEEDING STOPPED, A DRAIN WAS PLACED AND THE INCISION WAS CLOSED.. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22200630 ↗