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Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332811Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 84332811 ADAPTIX 28MM X 11MM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000203016), received between Jul 6, 2022 and Dec 16, 2022 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Device problems

  • Migration2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Pain1

Recent adverse event reports

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

  • InjuryDec 16, 2022Migration; Migration

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A TLIF FOR BACK PAIN DUE TO FORAMINAL STENOSIS. IT WAS REPORTED THAT THE CAGE MIGRATED. THE PATIENT HAD BACK PAIN. THE DEVICE WAS REMOVED FOLLOWED BY AN ADDITIONAL SURGERY AND ALIF. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Patient problems: Pain

    MAUDE report 15994265 ↗
  • MalfunctionJul 6, 2022Migration; Migration

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A TLIF WITH BILATERAL PSRF FOR SPINAL STENOSIS AT L2-L5. IT WAS REPORTED THAT THE CAGE BACKED OUT FROM DISC SPACE FOLLOWING THE SURGERY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE DATE OF IMPLANT WAS ON (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14926163 ↗

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Sources and updates

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