Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332410Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000202897), received between Jun 7, 2021 and Feb 3, 2026 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (7 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.

• InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(6), STUDY ID (B)(6) AND INCIDENT TYPE AE, SUBEVENT NUMBER: 0. PRIMARY DIAGNOSIS: STENOSIS. DESCRIPTION: INCREASED BACK PAIN. ONSET DATE: 2025-04-01. OUTCOME STATUS: NOT RECOVERED/ NOT RESOLVED. INTERVENTIONS: ACTION. SUBTYPE: AE RESULT IN HOSPITALIZATION, ACTION RESULT: NO ACTION. SUBTYPE: ANU. OTHER ACTION(S) TAKEN, ACTION RESULT: NO ACTION. SUBTYPE: DID THE AE RESULT IN ANY TREATMENT, ACTION RESULT: NO. SITE SERIOUSNESS ASSESSMENT: THERE IS NO CONGENITAL ANOMALY, DEATH, DISABILITY, HOSPITALIZATION, LIFE THREATENING AND MEDICAL INTERVENTION. SPONSOR ASSESSMENT: CAUSAL RELATED TO PROCEDURE AND NOT RELATED TO ANY DEVICE. DIAGNOSTICS: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: MRI WITHOUT CONTRAST1 ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED. ACTION RESULT: YES. EVENT: IT WAS REPORTED THAT THE PATIENT RETURNS TO OFFICE "WITH RECURRENT BACK AND RIGHT LEG PAIN OF UNCERTAIN ETIOLOGY AND PLAN IS TO GET LUMBAR MRI. ADDITIONAL INFORMATION WAS RECEIVED THAT PATIENT OUTCOME: RECOVERING/RESOLVING SITE SERIOUS ASSESSMENT: SEVERITY OF ADVERSE EVENT I

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 24243879 ↗
• InjuryFeb 18, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING MIS TLIF USING VOYAGER AND ADAPTIX IN CONJUNCTION WITH OARM & S8 NAVIGATION. IT WAS REPORTED THAT THE CAGE WAS SHOWN TO HAVE COMPLETELY MIGRATED OUT OF THE DISC SPACE. LEVELS IMPLANTED AT L5/S1. PATIENT WAS READMITTED FOR REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS NOT DELIVERED AS A DEFECTIVE PRODUCT AND THERE IS NO MANUFACTURING ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21402220 ↗
• InjuryDec 3, 2024Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING L2/3 PLIF S PINAL THERAPY. IT WAS REPORTED THAT THE RIGHT PEDICLE OF L2 HAD FRACTURED, RESULTING IN INSTABILITY AND BACKOUT OF THE CAGE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE IS A DELAY OF GREATER THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20830464 ↗
• InjurySep 25, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH MEDICAL HISTORY OF ANTERIOR LUMBAR FUSION AT L2/4 30 YEARS AGO WITH INTERBODY IMPLANT. PROCEDURE PERFORMED WAS FUSED RANGE EXTENSION, PS REPLACEMENT, AND CAGE REINSERTION. IT WAS REPORTED THAT THE PATIENT DEVELOPED NEUROLOGICAL SYMPTOMS DUE TO CAGE BACKOUT USED IN L4/5 TLIF AS A RESULT OF LOOSENING OF PEDICLE SCREW (PS) IN S. THIS SURGERY IS A REPEATED SURGERY. DATE OF INITIAL SURGERY WAS (B)(6), 2023. ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. PS REPLACEMENT, FUSED RANGE EXTENSION AND CAGE REINSERTION. ALSO, THE LOOSENESS OF THE PEDICLE SCREW INSERTED IN S.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 17805493 ↗
• InjuryAug 29, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PLIF THERAPY. LE VEL AT WHICH IMPLANT PERFORMED WAS L4-S. IT WAS REPORTED THAT THE CAGE BACKED OUT. THE ADDITIONAL SURGERY WAS PERFORMED. AFTER IT WAS REMOVED ONCE, THEN INSERTED THE SAME ON (B)(6), 2023. WHICH CAGE CAME OFF AND INSERTED INTO THE RIGHT SIDE IS UNKNOWN. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639175 ↗
• InjuryAug 29, 2023Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PLIF THERAPY. LE VEL AT WHICH IMPLANT PERFORMED WAS L4-S. IT WAS REPORTED THAT THE CAGE BACKED OUT. THE ADDITIONAL SURGERY WAS PERFORMED. AFTER IT WAS REMOVED ONCE, THEN INSERTED THE SAME ON (B)(6) 2023. WHICH CAGE CAME OFF AND INSERTED INTO THE RIGHT SIDE IS UNKNOWN. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17639168 ↗
• InjuryAug 4, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TLIF AT L5-S1 S PINAL THERAPY. IT WAS REPORTED THAT THE CAGE SUBSIDED POSTERIORLY AND REMOVED POSTERIORLY. PATIENT IS STABLE. PATIENT HAD CAGE REMOVED POSTERIORLY AND THEN UNDER WENT AN OLIF AT THAT LEVEL TO REPLACE THE TLIF CAGE. A REVISION SURGERY WAS NEEDED FOR THIS SURGERY, SURGEON TOOK CAGE OUT AND PERFORMED AN ALIF ON THIS PATIENT. FIRST CAGE SUBSIDED ON (B)(6) 2021. SECOND CAGE SUBSIDED ON (B)(6) 2021. THERE WAS NO PATIENT COMPLICATION/ SYMPTOMS AS A RESULT OF THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272758 ↗
• MalfunctionJun 7, 2021Migration; Migration

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH INTERBODY FUSION WITH ADAPTIX CAGE FOR SPINAL THERAPY. IT WAS REPORTED THAT POST OP THE CAGE MIGRATE TO POSTERIOR. THE SURGERY WENT WELL. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11945099 ↗