Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332406Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000202859), received between Sep 13, 2021 and Mar 2, 2025 — classified as 5 injuries, 1 malfunction.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2025Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR L5/S STENOSIS. PROCEDURE PERFORMED WAS TLIF. LEVEL AT WHICH THE IMPLANT PERFORMED WAS L5/S. IT WAS REPORTED THAT AFTER INSERTING THE CAGE, THE INSERTER WAS TRIED TO REMOVE, BUT IT WAS DIFFICULT TO REMOVE AS THE INNER SHAFT WAS HARD TO ROTATE, SO THE CAGE WAS REMOVED. AFTER THE CAGE WAS REMOVED FROM THE INSERTER AND WHEN IT WAS TRIED TO INSTALL AGAIN TO THE INSERTER, IT COULD BE INSTALLED WITHOUT ANY PROBLEMS. SO A NEW CAGE WAS OPENED, INSTALLED TO THE INSERTER AGAIN, AND INSERTED. AFTER INSERTION, IT WAS THE SAME, THE ROTATION OF INNER SHAFT WAS HARD BUT IT COULD BE REMOVED SOMEHOW, SO THE CAGE WAS IMPLANTED AS IT IS. THE INTERVERTEBRAL SPACE WAS NARROW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21500944 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT L4/5 MINIMALLY INVASIVE SURGERY - POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AND DEPLOYED CAGES ON BOTH SIDES DUE TO SPINAL CANAL STENOSIS AND INTERVERTEBRAL FORAMEN STENOSIS. AFTER L4/5 PLIF,  PYOGENIC SPONDYLITIS DEVELOPED DUE TO A CAGE. PAIN IN THE SURGICAL SITE DID NOT SUBSIDE DUE TO POST-OPERATIVE INFECTION. THE INFECTION CONDITION WAS CONFIRMED IN THE AREA AROUND THE CAGE; HOSPITALIZATION PERIOD WAS EXTENDED AND REPEAT SURGERY WAS PERFORMED FOR CAGE REMOVAL. DELAYED ONSET OF PAIN DUE TO INFECTION. THERE WAS NO PRODUCT DEFECT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19915695 ↗
• InjuryAug 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT L4/5 MINIMALLY INVASIVE SURGERY - POSTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AND DEPLOYED CAGES ON BOTH SIDES DUE TO SPINAL CANAL STENOSIS AND INTERVERTEBRAL FORAMEN STENOSIS. AFTER L4/5 PLIF,  PYOGENIC SPONDYLITIS DEVELOPED DUE TO A CAGE. PAIN IN THE SURGICAL SITE DID NOT SUBSIDE DUE TO POST-OPERATIVE INFECTION. THE INFECTION CONDITION WAS CONFIRMED IN THE AREA AROUND THE CAGE; HOSPITALIZATION PERIOD WAS EXTENDED AND REPEAT SURGERY WAS PERFORMED FOR CAGE REMOVAL. DELAYED ONSET OF PAIN DUE TO INFECTION. THERE WAS NO PRODUCT DEFECT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 19915687 ↗
• InjuryJan 18, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTH CARE PROVIDER) REGARDING A PATIENT WITH FIXATION AND TTIF FOR TH12 VERTEBRAL FRACTURE FOR PERCUTANEOUS VERTEBROPLASTY (BKP) AND TRANSFORAMINAL THORACIC INTERBODY FUSION (TTIF) SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE HAS BACKED OUT. THE CAGE WAS REMOVED DURING A REVISION OF SURGERY. THERE WAS NEUROLOGICAL SYMPTOM DUE TO CAGE BACK OUT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 13287202 ↗
• InjuryJan 18, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTH CARE PROVIDER) REGARDING A PATIENT WITH FIXATION AND TTIF FOR TH12 VERTEBRAL FRACTURE FOR PERCUTANEOUS VERTEBROPLASTY (BKP) AND TRANSFORAMINAL THORACIC INTERBODY FUSION (TTIF) SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE HAS BACKED OUT. THE CAGE WAS REMOVED DURING A REVISION OF SURGERY. THERE WAS NEUROLOGICAL SYMPTOM DUE TO CAGE BACK OUT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Unspecified Nervous System Problem

  MAUDE report 13287201 ↗
• InjurySep 13, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE CAGE WAS IMPLANTED UNI-LATERAL WITH THE DOLPHIN NOSE TIP RIGHT AT THE ANTERIOR EDGE OF THE BODY. POST OP SCANS SHOWS 5 DAYS AFTER SURGERY THE CAGE STARTED TO MIGRATE POSTERIORLY AND AT 19 DAYS, THE CAGE WAS SIGNIFICANTLY TOWARDS THE POSTERIOR WALL OF THE BODY AND EXPOSED. THE CAGE WAS THEN REMOVED 4 WEEKS POST OP. SCANS WERE TAKEN WHICH SHOWED THAT THE CAGE MIGRATED POSTERIORLY PATIENT RETURNED WITH PAIN. PATIENT IS ALIVE WITH INJURY.

  Patient problems: Pain

  MAUDE report 12458182 ↗