T2 STRATOSPHERE™ Expandable Corpectomy System NAV4360113Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSERTER NAV4360113 13MM INSERTER · Class 2
All models of T2 STRATOSPHERE Expandable Corpectomy System (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169611863), received between Aug 19, 2022 and Mar 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanics Altered1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CONNECTION PRONGS AT THE END OF THE INSERTER BENT AND SNAPPED OFF CAUSING THE INSERTER TO NO LONGER BE OF USE AND ONE OF THE ARMS OF THE REMOVAL TOOL SNAPPED OFF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TYPE OF PROCEDURE INVOLVED DURING THE INCIDENT WAS A CORPECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24588007 ↗MalfunctionAug 19, 2022Mechanics Altered; Mechanics Altered
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE IN A PATIENT DIAGNOSED WITH THORACIC TUMOR. IT WAS REPORTED THAT INSERTER WOULD NOT DISENGAGE FROM IMPLANT AFTER IT WAS EXPANDED. MANEUVER TO TAKE INSERTER OFF OF IMPLANT, ENDED UP MAKING THE IMPLANT OFF PLANE IN THE CORONAL VIEW. THERE WAS NO PATIENT SYMPTOM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15257127 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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