Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332412Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 84332412 ADAPTIX 24MM X 12MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000202910), received between Nov 29, 2021 and Feb 12, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Migration” (2 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.
Reports received per month
Most reported problems
Device problems
- Migration2
- Device Dislodged or Dislocated1
Patient problems
- Pain3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryFeb 12, 2026Device Dislodged or Dislocated
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE BECAME DISLOCATED, RESULTING IN PAIN SYMPTOMS. THE PATIENT RETURNED DUE TO A DISLOCATION OF THE ADAPTIX CAGE, AND AN ADDITIONAL SURGERY WAS PERFORMED TO RELOCATE THE ADAPTIX CAGE AT THE L4-L5 LEVEL. NO ADDITIONAL COMPLICATIONS RELATED TO THE EVENT WERE REPORTED. THE IMPLANT WAS NOT REMOVED; INSTEAD, THE L4-L5 CAGE WAS RELOCATED AND THE BILATERAL L4 SCREWS WERE UPSIZED. NO THERAPY WAS ADMINISTERED DURING THE EVENT.
Patient problems: Pain
MAUDE report 24329565 ↗InjurySep 13, 2022Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PRE-OP DIAGNOSIS FOR HARDWARE REMOVAL OF FAILED TLIF AT L5/S1. PROCEDURE OR TECHNIQUE USED WAS L3-S1 TLIF AND POSTERIOR LUMBAR FUSION. IT WAS REPORTED THAT THE CAGE BACKED OUT OF THE DISC SPACE. PATIENT HAD BACK PAIN. ADDITIONAL SURGERY WAS PERFORMED FOR REMOVAL OF THE EXTRUDED CAGE AT L5/S1.
Patient problems: Pain
MAUDE report 15408367 ↗InjuryNov 29, 2021Migration; Migration
INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OP DIAGNOSIS FOR MISTLIF THERAPY. IT WAS REPORTED THAT THE CAGE BACK OUT. PATIENT HAD LOWER BACK PAIN SINCE 15TH DAYS RADIATING TO LOWER LIMB. R>L. CT SCAN SHOWED DISPLACED FUSION DEVICE AT L5 S1 LEVEL CAUSING STENOSIS AFTER THE 1ST SURGERY. REVISION CASE DONE ON (B)(6) 2021. AND THE CAGE WAS EXPLANTED BY OPEN REVISION SURGERY. THE CAGE WAS REPLACED BY PATIENT AUTOGRAFT ONLY. NO CAGE WAS IMPLANTED AGAIN. AFTER THE REVISION SURGERY PATIENT IS OK.
Patient problems: Pain
MAUDE report 12888830 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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