Anteralign Spinal System with Titan nanoLock Surface technology 46841220Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000510787), received between Nov 16, 2022 and Sep 12, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING L 3/4 OLIF PROCEDURE IN A PATIENT DIAGNOSED WITH L3/4/5 LCS. IT WAS REPORTED THAT THE OPERATION WAS PERFORMED IN THE FIRST PERIOD, IN WHICH THE OLIF 2 INTERVERTEBRAL AND POSTERIOR FUSIONS WERE DIVIDED INTO TWO PERIODS. THE FIRST TERM WAS COMPLETED BY INSERTING A CAGE, PLATE & SCREW BETWEEN THE 2 INTERVERTEBRAL OF L3/4/5. THE SECOND PERIOD OF POSTERIOR FIXATION WAS PERFORMED WITH NON-MEDTRONIC HARDWARE. BETWEEN THE FIRST AND SECOND PERIOD, ABOUT ONE-THIRD OF THE L3/4 CAGE CAME OFF IN ONE WEEK. THE CAGE THAT HAD COME LOOSE WAS TO BE DRIVEN IN AGAIN, SO ONLY THE SCREWS IN THE PLATE WERE REMOVED, THE PLATE AND CAGE WERE DRIVEN IN AS THEY WERE, FITTED BETWEEN THE VERTEBRAE, AND FINISHED AFTER COMPRESSION WAS APPLIED AT THE TIME OF POSTERIOR FIXATION. THERE WAS A DELAY OF LESS THAN 60 MINS. 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 20208233 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIA GNOSIS FOR DISC DEGENERATIVE DISEASE. PROCEDURE PERFORMED WAS PRONE OLIF THERAPY. LEVELS IMPLANTED L2-3-4-5. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT AN ANTERALIGN PLATE ON THE CAGE AT ANY OF THE 3 LEVELS, COULD NOT GET THE PLATE TO ENGAGE AND ATTACH TO THE CAGE L3-4 CAGE BACKED OUT AND WAS NOTICED ON JULY 17 NOTICED ON POST OP CT FOR MAZOR STAGE SURGERY ON (B)(6) ENDED UP REVISING INCISION AND REPOSITIONED CAGE THEN DID AN L2-S2 POSTERIOR FUSION THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 WITH 3 CAGES IMPLANTED AND 3 PLATES IMPLANTED AND EXPLANTED ON THIS DATE. ONE OF THE THREE CAGES HAD SHIFTED ON (B)(6) 2023. ON (B)(6) 2023, 2ND SURGERY WAS PERFORMED TO REPOSITION THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538563 ↗
• MalfunctionAug 14, 2023Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH * PRE-OPERATIVE D IAGNOSIS FOR DISC DEGENERATIVE DISEASE. PROCEDURE PERFORMED WAS PRONE OLIF THERAPY. LEVELS IMPLANTED L2-3-4-5. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO INSERT AN ANTERALIGN PLATE ON THE CAGE AT ANY OF THE 3 LEVELS, COULD NOT GET THE PLATE TO ENGAGE AND ATTACH TO THE CAGE L3-4 CAGE BACKED OUT AND WAS NOTICED ON (B)(6) NOTICED ON POST OP CT FOR MAZOR STAGE SURGERY ON (B)(6) ENDED UP REVISING INCISION AND REPOSITIONED CAGE THEN DID AN L2-S2 POSTERIOR FUSION THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2023 WITH 3 CAGES IMPLANTED AND 3 PLATES IMPLANTED AND EXPLANTED ON THIS DATE. ONE OF THE THREE CAGES HAD SHIFTED ON (B)(6) 2023. ON (B)(6) 2023, 2ND SURGERY WAS PERFORMED TO REPOSITION THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538522 ↗
• InjuryNov 16, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A CAGE-PLATE-SCREW CONSTRUCT IN AN OLIF FOR LEVELS 3-4 FOR ANOTHER MECHANICAL COMPLICATION. IT WAS REPORTED THAT THE ORIGINAL SURGERY WAS OLIF 3-5 ON (B)(6) 2022. THE 3-4 CAGE BACKED OUT. ON (B)(6) 2022, THEY REVISED BY PUSH IN THE CAGE AND ADDING THE INTEGRATED PLATE AND SCREW. ON PREVIOUS REVISION THE CAGE WAS INSPECTED AND NEW BIOLOGICAL GRAFT WAS USED. THE IMPLANT BACKED OUT PRIOR TO FUSION. ON (B)(6) 2022, THE PATIENT CAME TO CLINIC AND SHOWED THAT THE CAGE/PLATE/SCREW CONSTRUCT BACKED OUT. THE PRODUCTS WERE REPLACED WITH AN ALTERNATE DEVICE AND ADDITIONAL FIXATION. THE PATIENT IS ASYMPTOMATIC. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15803516 ↗