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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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

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

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