Anteralign Spinal System with Titan nanoLock Surface technology 4680005Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000193942), received between Feb 1, 2023 and Mar 31, 2026 — classified as 10 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 10 most recent of 10 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 24740085 ↗
• MalfunctionMar 12, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A INSERTER TRAIL USED ON PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING A LATERAL APPROACH SPINE FUSION, THE TIP OF THE INSERTER BROKE OFF IN THE TRIAL, RENDERING BOTH THE TRIAL AND INSERTER UNUSABLE DURING THE CASE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. 2025-AUG-08 E1 (REP): ADDITIONAL INFORMATION RECEIVED THAT PROCEDURE INVOLVED WAS DIRECT LATERAL INTERBODY FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24586269 ↗
• 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 24555957 ↗
• MalfunctionFeb 27, 2026Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OBLIQUE LUMBAR INTERBODY FUSION. IT WAS REPORTED THAT, AS THE TRIAL WAS BEING INSERTED THE SURGEON FELT/HEARD SOMETHING BREAK AND WENT TO REMOVE THE TRIAL TO FIND THAT THE THREADED TIP OF THE INSERTER HAD BROKEN OFF INSIDE THE TRIAL AND THE TRIAL WAS IN THE DISC SPACE AND NO LONGER ATTACHED TO THE INSERTER AND THE THREADED HOLE WAS NOW BLOCKED WITH THE BROKEN TIP OF THE INSERTER. THE THREADED SHAFT WAS BENT IN THE PROCESS OF TRYING TO THREAD IN TO THE UNBLOCKED HOLE OF THE TRIAL THAT WAS INSIDE OF THE PATIENT TO ASSIST IN THE REMOVAL OF THE TRIAL THAT WAS STUCK DUE TO THE BREAKING OF THE THREADED TIP OF THE INSERTER THE TRIAL BROKE OFF THE INSERTER WHILE INSERTED IN THE DISC SPACE. ATTEMPTS WERE MADE TO REMOVE IT WITH A KOCHER, A ANTERALINGN THREADED SHAFT IN THE UNBLOCKED THREADED HOLE (MADE DIFFICULT BY POSITION AND PATIENT ANATOMY). SURGEON REMOVED BONE FROM THE LATERAL ASPECT OF THE VERTEBRAL BODIES AND WAS ABLE TO GRIP THE TRIAL AND REMOVE WITH A LONG KOCHER. THIS ADDED ABOUT 30 MINUTES TO THE PATIENTS PROCEDURE. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24468552 ↗
• MalfunctionDec 12, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING OLIF-OBLIQUE LA TERAL INTERBODY FUSION SPINAL THERAPY. IT WAS REPORTED THAT THE TIP OF THE INSERTER BROKE OFF IN THE TRIAL WHEN WE WERE TRIALING. WE WERE ABLE TO SAFELY REMOVE THE TRIAL WHICH HAD THE BROKEN TIP STILL THREADED INTO IT. NO FRAGMENTS WERE LEFT BEHIND. 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 23787289 ↗
• MalfunctionMay 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN OBLIQUE LATERAL INTERBODY FUSION THERAPY FOR DEGENERATION. IT WAS REPORTED THAT THE INSERTER SHAFT BROKE, LEAVING A FRAGMENT OF THE TIP INSIDE THE ANTERALIGN IMPLANT. FRAGMENTS REMAINS IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TIP OF INSERTER SHAFT BROKE OFF

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21982957 ↗
• MalfunctionMay 8, 2025Break; Break

  INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED IN OBLIQUE LATERAL INTERBODY FUSION THERAPY FOR DEGENERATION. IT WAS REPORTED THAT THE INSERTER SHAFT BROKE, LEAVING A FRAGMENT OF THE TIP INSIDE THE ANTERALIGN IMPLANT. FRAGMENTS REMAINS IN THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TIP OF INSERTER SHAFT BROKE OFF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 21982937 ↗
• MalfunctionApr 22, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT, THE INSTRUMENT INTERBODY TRIAL SHAFT'S TIP BROKE OFF DURING INSERTION AND REMAINS IN THE TRIAL. PROCEDURE/TECHNIQUE PERFORMED WAS ANTERIOR LUMBAR INTERBODY FUSION. THERE WERE NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21880250 ↗
• MalfunctionNov 23, 2023Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LUMBAR DEGENERATIVE DISEASE. PROCEDURE PERFORMED WAS SIMULTANEOUS ANTERIOR-POSTERIOR FIXATION OF THE LUMBAR SPINE. LEVEL AT WHICH IMPLANT WAS PERFORMED L2/S1. IT WAS REPORTED THAT AFTER THE CAGE WAS INSTALLED IN L5/S, IT DID NOT COME OFF THE INSERTER. THEREFORE, THE KNOB WAS TURNED AS MUCH AS POSSIBLE, RESULTING IN THE THREADED PART OF THE INSERTER SHAFT BREAKING OFF AND REMAINING IN THE HOLE OF THE CAGE. INSERTER WAS BROKEN. THE PHYSICIAN BELIEVED THAT THERE WOULD BE NO PARTICULAR HARM, SO IT WAS LEFT IN PLACE. BECAUSE OF THE PROTRUDING ILIUM, THE CAGE WAS OBLIQUELY PLACED IN THE INSERTER AND INSERTION WAS PERFORMED. THE PHYSICIAN IS AWARE THAT L5/S IS NOT APPLICABLE. INSTRUMENT OR IMPLANT DEBRIS LEFT IN THE PATIENT'S BODY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. THE INNER SHAFT OF THE INSERTER IS THE ONLY ONE THAT WAS DAMAGED, SO IT IS BELIEVED THAT THERE WAS NO DAMAGE TO THE CAGE. THE CAGE IS ALREADY PLACED IN THE BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18202918 ↗
• MalfunctionFeb 1, 2023Break; Break

  NFORMATION WAS RECEIVE FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A SPINAL PRODUCT USING AN INSERTER IN AN L2-5 OLIF FOR AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE HCP WAS USING THE INSERTER WITH A TRIAL ATTACHED TO OPEN UP THE DISC SPACE BY MOVING THE INSERTER CEPHALAD AND CAUDAL BACK AND FORTH MULTIPLE TIMES WHEN THE INNER SHAFT BROKE RIGHT ABOVE THE THREADS. ANOTHER INSERTER SHAFT IN THE SET WAS USED TO ATTACH TO THE OTHER THREADED HOLE ON THE TRIAL AND THEY WERE ABLE TO USE THE SLAP HAMMER TO REMOVE THE TRIAL. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276325 ↗