Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332408Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 84332408 ADAPTIX 24MM X 8MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000202873), received between Dec 22, 2021 and Nov 10, 2023 — classified as 2 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
Patient problems
- Fever1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2023Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PREOPERATIVE DIAGNOSIS FOR LUMBAR SPINAL STENOSIS. PROCEDURE OR THERAPY PERFORMED WAS L5/S MIS -TLIF. IT WAS REPORTED THAT THE CAGE BACKED OUT AFTER SURGERY. GRIPPING BY SHAFT WAS DONE DURING CAGE REMOVAL. THE GRIPPING PORTION AT THE TIP OF THE SHAFT WAS BROKEN DUE TO THE TWISTING MOTION DURING REMOVAL. IT WAS BURIED IN THE CAGE. SINCE THE REAR PORTION OF THE CAGE HAD ALREADY EMERGED, REMOVAL WAS PERFORMED WITH NEEDLE-NOSE PLIERS. DUE TO THE NARROW OPERATIVE FIELD, AN EXTERNAL TUBE WAS NOT USED. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. DATE OF INITIAL SURGERY WAS (B)(6) 2022.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18108803 ↗InjuryDec 22, 2021Migration; Migration
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLIF SPINAL THE RAPY AT L4/5 FOR LCS. IT WAS REPORTED THAT APPROXIMATELY 2 MM THE CAGE BACKED OUT. AS AN ADDITIONAL SURGERY THE CAGE WAS REMOVED AND ILIUM INSERTED. THE SCREWS ON BOTH SIDES OF L5 BECAME LOOSE. THE PATIENT HAS A FEVER AND IS SUSPECTED OF BEING INFECTED. THERE WAS NO FURTHER INFORMATION REPORTED.
Patient problems: Fever
MAUDE report 13058540 ↗
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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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