Adaptix™ PEEK Interbody System with Nanotechnology 74332410Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00814216028280), received between Mar 30, 2026 and Mar 30, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Migration

  INFORMATION PROVIDED FROM MEDTRONIC PRODUCT EVENT SUMMARY REPORT (B)(4) RECEIVED ON (B)(6) 2026: (B)(6) 2026 (B)(6) (REP, HCP): INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING TRANSFORAMINAL LUMBAR INTERBODY FUSION SPINAL THERAPY AT L3/4 AND L4/5. IT WAS REPORTED THAT THE IMPLANT BACKED OUT AT THE L4/5 LEVEL. THERE WAS A LACK OF SOLID FUSION AT THE AFFECTED LEVEL. THE PATIENT WAS SCHEDULED FOR ADDITIONAL SURGERY TO REMOVE THE IMPLANT AT A LATER DATE. IT WAS UNKNOWN IF THERE WERE ANY PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. (B)(6) 2026 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT HAD LINGERING BACK PAIN POST OPERATIVELY. PATIENT HAD A PRE-OPERATIVE DIAGNOSIS OF LUMBAR RADICULOPATHY NEEDING A L3-L5 FUSION. (B)(6) 2026 (REP): ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE THAT THE 2 SCREWS WERE LOOSENED AND THEY WERE EXPLANTED ON THE REVISION SURGERY PERFORMED ON (B)(6) 2026.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 24713248 ↗