Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332814Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 84332814 ADAPTIX 28MM X 14MM · 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 00763000203047), received between Feb 21, 2022 and Feb 21, 2022 — 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 21, 2022Migration; Migration
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT PREVIOUSLY IMPLANTED WITH 2 CAGES IN A 2 LEVEL LUMBAR FUSION ON (B)(6) 2021 AT L3/L4 AND L4/L5. IT WAS REPORTED THAT THE PATIENT HAD BACK PAIN IN THE WEEK OF (B)(6) 2022. SCAN SHOWED ONE OF THE 2 INTERBODY CAGES (ADAPTIX CAGE) MIGRATED POSTERIORLY. THE SURGEON PERFORMED AN EXPLANT OF THE MIGRATED INTERBODY CAGE ON (B)(6) 2022. THE PATIENT HAD FALLEN SEVERAL TIMES (6 TIMES). ACCORDING TO THE SURGEON¿S OPINION, THE FALL LED TO THE CAGE MIGRATION. THE OTHER CAGE AT L3/L4 WAS STILL IN PLACE. THE SURGEON REPLACED 4 OF THE 6 SCREWS THAT WERE LOOSE DUE TO THE PATIENT¿S NUMEROUS FALLS AND RE-APPLIED THE RODS WITH NEW SET CAPS. THE PATIENT WAS GOING TO BE DISCHARGED TO AN ASSISTED LIVING ARRANGEMENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: Pain
MAUDE report 13567431 ↗
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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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