Anteralign Spinal System with Titan nanoLock Surface technology 4680009Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000193980), received between Apr 18, 2024 and Jun 9, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN A SPINAL THERAPY. IT WAS REPORTED THAT THE SCREWDRIVER TIP BROKE OFF IN A SCREW AND THE SCREWDRIVER COULD NOT BE REUSED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25442675 ↗
• MalfunctionJun 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DIRECT LATERAL INTERBODY FUSION(DLIF) SPINAL THERAPY. IT WAS REPORTED THAT DRIVER TIP BROKE OFF IN SCREW HEAD.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22274971 ↗
• MalfunctionJan 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DROVER, AND INSERTER USED ON A PATIENT IMPLANTED WITH A MINIPLATE HAVING L3-L5 OBLIQUE LATERAL INTERBODY FUSION (OLIF) THERAPY. IT WAS REPORTED THAT WHILE INSERTING THE BONE BOLT THROUGH THE PLATE INTO THE BONE, THE BOLT ENDED UP COLD WELDING TO THE DRIVE, THE ACTUAL BOLT WAS STILL ON THE DRIVER AND CANNOT BE REMOVED. ON TRIALING THE 6-DEGREE, THE DISTAL THREADED PORTION OF THE DRIVER ENDED UP BREAKING OFF INSIDE THE TRIAL. THE TRIAL WAS REMOVED AND THE BROKEN THREAD WAS STUCK INSIDE OF IT. THE BONE BOLT THAT WAS USED TO THREAD THROUGH THIS MINI PLATE AND INTO THE BONE ENDED UP COMPROMISING THE PLATE. IT WAS REPLACED WITH A NEW BOLT AND PLATE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251509 ↗
• MalfunctionJan 28, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT INSERTER DISTAL THREADED TIP BROKE OFF INSIDE THIS TRIAL. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21251133 ↗
• MalfunctionJan 18, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE REPRESENTATIVE) REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT WHEN THE DOCTOR WAS HAMMERING IN THE AWL, THE AWL GOT BENT AND STUCK INSIDE THE AWL SLEEVE AND THE DRIVER BROKE OFF. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21186421 ↗
• MalfunctionDec 9, 2024Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE REPORTED PRODUCT WAS THROWN AND WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20876877 ↗
• MalfunctionMay 22, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING NORMAL USE OF REPORTED INSTRUMENT. IT WAS REPORTED THAT, THE TIP OF INSTRUMENT WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLI CATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19368989 ↗
• MalfunctionApr 18, 2024Break; Break

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT, THE TIP OF DRIVER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132034 ↗