Anteralign Spinal System with Titan nanoLock Surface technology 4680004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000193935), received between Mar 2, 2026 and Mar 31, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA MANUFACTURER REPRESENTATIVE REGARDING INSERTERS. IT WAS REPORTED THAT THE TWO PIECE ANTERALIGN INSERTER WILL NOT THREAD INTO ONE ANOTHER. MALFUNCTION WAS DETECTED WHILE INSPECTING THE INSTRUMENTS PRIOR TO THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740031 ↗
• MalfunctionMar 10, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN INSERTER USED FOR OLIF PROCEDURE. IT WAS REPORTED THAT  THE SHAFT COULD NOT BE CONNECTED TO THE DEVICE. IT CAN BE CONNECTED IF FORCEFULLY PUSHED, BUT IT MIGHT BE THAT ONE OF THE INSTRUMENTS IS BENT. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24555927 ↗
• MalfunctionMar 2, 2026Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INNER SHAFT OF THE DEVICE WOULD NOT ADVANCE THROUGH THE INSERTER. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS ALREADY USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24480402 ↗