Anteralign Spinal System with Titan nanoLock Surface technology 4680008Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000193973), received between May 7, 2024 and Aug 6, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2026Break

  Information was received from a manufacturer representative regarding a device used for Spinal therapy. It was reported that during inspection, it was noticed that the ball joint driver tip was damaged and in need of replacement. There was no patient involvement reported. There were no further complications reported regarding the event. Additional information was received from the manufacturer representative stating that the very tip of the driver was broken/sheared off. The damage was discovered prior to instrument cleaning and sterilization in the MDRD department.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50152799 ↗
• MalfunctionMay 27, 2025Material Twisted/Bent; Material Twisted/Bent

  INFORMATION WAS RECEIVED FROM A HEALTHCARE FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE DRIVER WAS 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 22085689 ↗
• MalfunctionFeb 3, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5-S1 OLIF FOR AN INDICATION OF SPINAL STENOSIS. IT WAS REPORTED THAT THE SCREW HOLDING TIP OF THE BALLJOINT DRIVER BROKE OFF. 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 21289639 ↗
• MalfunctionNov 18, 2024Break; Mechanical Jam; Break; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER AND HANDLES WERE BROKEN, THE DRIVER GOT STUCK ON A SCREW. THERE WERE NO PATIENT SYMPTOMS AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE DRIVER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20705032 ↗
• MalfunctionNov 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE TIP OF THE DRIVER COLD WELDED TO THE SCREW DURING OPERATION AND SNAPPED OFF. THE TIP WAS IN THE PATIENT COLD WELDED TO THE SCREW. THE BROKEN TIP WAS REMOVED DURING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20628002 ↗
• MalfunctionMay 7, 2024Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT TIP BROKE OFF.  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 19261104 ↗