Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332407Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000202866), received between Apr 27, 2021 and Nov 1, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (4 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.

• InjuryNov 1, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAG NOSIS FOR LUMBAR SPONDYLOLISTHESIS. PROCEDURE PERFORMED WAS L4/5 MPPLIF, L5/S PLIF L4 TO S2AI POSTERIOR FIXATION. LEVEL AT WHICH THE IMPLANT WAS PERFORMED WAS L4 TO S2AI. PATIENT HAD A MEDICAL HISTORY OF DIALYSIS. IT WAS REPORTED THAT THE PATIENT HAD LOWER BACK PAIN. THE LOWER BACK PAIN DID NOT IMPROVE, SO A CT SCAN WAS PERFORMED AND BACK-OUT WAS CONFIRMED. THERE WERE NO NEUROLOGICAL SYMPTOMS. ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT WAS CAGE REMOVAL AND BONE GRAFTING. INITIAL OPERATION WAS PERFORMED IN SEPTEMBER 28. NO PAIN AT ALL 3 DAYS AFTER THE FIRST OPERATION. SUBSEQUENTLY, THE PATIENT EXPERIENCED LOWER BACK PAIN. IT WAS ASSUMED THAT THE EVENT WAS CAUSED BY A HEMATOMA, AND IMAGING TESTS WERE NOT PERFORMED IMMEDIATELY. AFTER THE EXAMINATION, IT WAS DISCOVERED THAT THE CAGE HAD DISLODGED. AT THE TIME OF THE FIRST OPERATION, THE RIGHT SIDE WAS CONCAVE, AND THE CAGE ITSELF DID NOT MOVE AND FIT PERFECTLY. FOR DIALYSIS PATIENTS, IT WAS FIXATED WITHOUT HIGH RISK OF SCREW DEVIATION DUE TO COMPRESSION. THE ROD WAS STILL INSERTED AND IT COULD

  Patient problems: Pain

  MAUDE report 15705658 ↗
• InjurySep 7, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH A CAGE IN AN L3/4 TLIF AND REMOVED ALONG WITH A CY INSERTION AT L3/4. IT WAS REPORTED THAT THE PATIENT HAD NEUROLOGICAL SYMPTOMS (DUE TO EMESIS) AND ONSET OF PAIN DUE TO CAGE BACKOUT. IMAGING FINDINGS CONFIRMED THAT THE CAGE MIGRATED WITHIN THE INTERVERTEBRAL DISC SPACE AND DISLODGEMENT OF 1/3 IN THE SPINAL CANAL WAS CONFIRMED. THEREFORE, THE CURRENT SURGERY WAS PERFORMED. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN THE OVERALL PROCEDURE TIME. AA+S5 WAS THE MDT PRODUCT USED IN THE INITIAL SURGERY. THE PATIENT'S MEDICAL HISTORY INCLUDED STEROID TRIAL (SLIGHT MOVEMENT AFTER THE PROCEDURE). NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: Pain; Unspecified Nervous System Problem

  MAUDE report 15368185 ↗
• 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 12272749 ↗
• InjuryApr 27, 2021Migration; Migration

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING AN IMPLANT USED FOR TLIF THERAPY. IT WAS REPORTED THAT THE SUPERIOR SET SCREW ON THE RIGHT SIDE OF THE PATIENT WAS CROSS-THREADED WHEN BROKE OFF. THIS ALLOWED THE ROD TO MOVE FREELY WITHIN THE SCREW HEAD. THIS LACK OF PROPER COMPRESSION ALLOWED FOR THE CAGE TO SUBSIDE. PATIENT OUTCOME WAS THAT SURGEON EXTRACTED THE TLIF CAGE AND THEN DID AN OLIF AT THE CORRESPONDING LEVEL WITH A DIVERGENCE-L CAGE AND A DIVERGENCE PLATE AND SCREWS. THE TLIF CAGE WAS REMOVED AND THEN DID AN OLIF AT THE SAME LEVEL. THE CAGE SUBSIDED POSTERIORLY INTO THE PATIENTS SPINAL COLUMN. NO NEUROLOGICAL DAMAGE OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11731170 ↗