Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology 84332813Recalls & reported problems
Medtronic Sofamor Danek, Inc. · SPACER 84332813 ADAPTIX 28MM X 13MM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000203030), received between May 21, 2026 and May 21, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Device problems
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2026Migration
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, CLINICAL STUDY) REGARDING A PATIENT WITH CLINICAL ID: (B)(6) AND STUDY NAME AND NUMBER TLIF IDE PIVOTAL - (B)(6). IT WAS REPORTED THAT AN INTERBODY IMPLANT SUBSIDENCE AT THE 12-MONTH FOLLOW-UP WAS IDENTIFIED IN THE PATIENT. THE INVESTIGATOR HAS NOT REPORTED SUBSIDENCE FOR THIS SUBJECT. NO FURTHER COMPLICATEIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE STATING THAT IT WAS UNKNOWN IF THERE WAS ANY REVISION SURGERY PERFORMED OR ANY FUTURE REVISION TO EXPLANT THE SUBSIDED IMPLANT. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25240591 ↗
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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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