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Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332809Recalls & reported problems

Medtronic Sofamor Danek, Inc. · SPACER 84332809 ADAPTIX 28MM X 9MM · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000202996), received between Feb 19, 2021 and Feb 19, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (1 report).

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

  • Migration1

Patient problems

  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 19, 2021Migration; Migration

    THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WAS MIGRATED AND PATIENT WAS BROUGHT BACK FROM THE INITIAL SURGERY COMPLETED ON (B)(6) 2021 FOR A REMOVAL/ REVISION AND REPLACEMENT OF THE L5-S1 ADAPTIX CAGE THAT WAS REPLACED WITH A CAPSTONE PTC CAGE. THE REVISION SURGERY WAS COMPLETED TODAY, (B)(6) 2021. PATIENT'S INITIAL SURGERY WAS COMPLETED ON (B)(6) 2021. WE HAD TO REMOVE AND REPLACE THE L5-S1 TLIF (ADAPTIX CAGE) (28MM X 9MM) DUE TO PATIENT COMPLAINING OF NEW LEG PAIN. AFTER COMPLETING A FOLLOW UP CT SCAN. IT WAS DETERMINED THAT THE CAGE HAD MIGRATED POSTERIORLY AND WAS AGGRAVATING THE NERVES. DR.(B)(6) REQUESTED TO USE THE "OLDER TECHNOLOGY" CAGE OF CAPSTONE-PTC AND INCREASED THE HEIGHT TO 10MM X 22MM CAGE (SHORTER LENGTH) AT L5-S1. HE ALSO COMMENTED ABOUT THE TEXTURE OF THE ADAPTIX CAGE BEING MUCH SMOOTHER THEN THE CAPSTONE- PTC CAGES. THERE WAS NO FURTHER COMPLICATION REPORTED.

    Patient problems: Pain

    MAUDE report 11347388 ↗

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Sources and updates

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