Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332409Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000202880), received between Dec 27, 2021 and Aug 22, 2025 — classified as 1 injury, 3 malfunctions.

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

• InjuryAug 22, 2025Migration; Migration

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT "CORRESPONDING PROCEDURE UTILIZED/ IMPLANTED INDEX SURGERY, (B)(6) 2024 SPINAL LEVEL WHERE TREATMENT STARTED WAS L4 AND ENDED L5. CORRESPONDING PROCEDURE EXPLANTED (1) ADDITIONAL SPINAL SURGERY, (B)(6) 2025.

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

  MAUDE report 22870298 ↗
• MalfunctionMar 5, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF (POSTERIOR LUMBAR INTERBODY FUSION). IT WAS REPORTED THAT AFTER INSERTING THE FIRST CAGE, BREAKAGE TO THE END PLATE WAS CONFIRMED. THEREFORE, A SECOND CAGE WAS NOT INSERTED AND ONLY BONE GRAFTING WAS IN PLACE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE CAGE (PRODUCT LINE ITEM 10) WRITTEN IN THE SOURCE INFORMATION WAS NOT IN THE PATIENT'S BODY, AND THERE WERE NO DEFECTS IN THE CAGE ITSELF. THE END PLATE OF THE VERTEBRAL BODY WAS D AMAGED WITH THE FIRST CAGE (PRODUCT LINE ITEM 20). DATE OF IMPLANTATION: (B)(6) 2025, NOT RETURNED DUE TO ONGOING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21523928 ↗
• MalfunctionDec 6, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING AN EVENT WHICH OCCURRED POST A CLINICAL STUDY (STUDY ID: (B)(6) L4-L5 TLIF PROCEDURE IN A PATIENT (PATIENT ID: (B)(6). IT WAS REPORTED THAT PATIENT DESCRIBES BURNING SENSATION IN LEFT LEG WHICH LEADS TO FATIGUE AND THE FEELING OF INABILITY TO LIFT IT. PAIN IS PRESENT IN SAME SPACE THAT WAS PRESENT PRIOR TO SURGERY. PATIENT FINDS IT CHALLENGING TO WALK. AS PER SPONSOR ASSESSMENT EVENT IS POSSIBLY RELATED TO PROCEDURE AND INTERVERTEBRAL BODY FUSION DEVICE. NOT RELATED TO TLIF GRAFTING MATERIAL AND POSTERIOR SUPPLEMENTAL FIXATION SYSTEM. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Ambulation or Postural Difficulties; Burning Sensation; Fatigue; Pain

  MAUDE report 20862368 ↗
• MalfunctionDec 27, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS FOR LUMBAR SPINAL CANAL STENOSIS. PLIF THERAPY WAS PERFORMED AT L4/5. IT WAS REPORTED THAT DURING THE POSTOPERATIVE FOLLOW-UP IT WAS REVEALED THAT THE CAGE WAS BACKED OUT. THE CAGE HAS PROTRUDED ABOUT 5 MM POSTERIORLY FROM THE POSTERIOR WALL. THERE WAS NO PATIENT SYMPTOM & THE PATIENT WAS UNDER OBSERVATION IN HOSPITAL. THERE ARE NO PLANS FOR ADDITIONAL SURGERY AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13091281 ↗