Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332812Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000203023), received between May 27, 2022 and Jan 9, 2025 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH CLINICAL ID (B)(4), STUDY ID (B)(4), INCIDENT TYPE AE SUBEVENT NUMBER: 0. PRIMARY DIAGNOSIS: STENOSIS DESCRIPTION: LOW BACK PAIN ONSET DATE: 2024-03-20 INTERVENTIONS: ACTION SUBTYPE: DENERVATION PROCEDURE ACTION RESULT: YES ACTION DATE: (B)(6) 2024 DENERVATION PROCEDURE TYPE: RADIOFREQUENCY ABLATION ACTION SUBTYPE: AE RESULT IN HOSPITALIZATION ACTION RESULT: NO ACTION SUBTYPE: ANY OTHER ACTION(S) TAKEN ACTION RESULT: NO ACTION SUBTYPE: DID THE AE RESULT IN ANY TREATMENT ACTION RESULT: YES ACTION SUBTYPE: DRUG THERAPY ACTION RESULT: YES ACTION SUBTYPE: INJECTION ACTION RESULT: YES INJECTION-1: INJECTION NAME: MEDIAL BRANCH BLOCK DATE: (B)(6) 2024 LEVELS: L3-L4 DETAILS: DIAGNOSTIC INJECTION-2: INJECTION NAME: MEDIAL BRANCH BLOCK DATE: (B)(6) 2024 LEVELS: L3-L4 DETAILS: DIAGNOSTIC PATIENT OUTCOME: RECOVERING/RESOLVING DIAGNOSTIC: ACTION TYPE: DIAGNOSTIC ACTION SUBTYPE: WERE ANY DIAGNOSTIC TEST PERFORMED ACTION RESULT: NO ADVERSE EVENT INFO: DOES THE ADVERSE EVENT INVOLVE A LUMBOSACRAL SPINAL LEVEL: YES IF YES, LEVELS INVOLVED: L3-L4 SITE SERIOUSNESS ASSESSMENT: THERE IS NO CONGENITAL

  Patient problems: Pain

  MAUDE report 21109821 ↗
• InjuryMay 27, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH ALIF THERAPY. IT WAS REPORTED THAT THE CAGE WAS PLACED AS PART OF MIS TLIF. CAGE WAS IMPLANTED SUCCESSFULLY. POST INITIAL SURGERY CAGE MIGRATED & SPIT POSTERIORLY AND IT HAD TO BE REMOVED. AN ALIF WAS PERFORMED TO STABILIZE THE PATIENT'S SPINE. THE PATIENT HAD LEG PAIN FOLLOWING THE INITIAL SURGERY DUE TO MIGRATED CAGE. THERE WERE NO SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 14520582 ↗