T2 STRATOSPHERE Expandable Corpectomy System 436120ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169634848), received between Mar 3, 2022 and Mar 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (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

Recent adverse event reports

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

• MalfunctionMar 21, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A CAGE IMPLANTED IN A PATIENT DURING A T12 SUBTOTAL REMOVAL, VERTEBRAL BODY REPLACEMENT FOR A BURST T12. IT WAS REPORTED THAT WHEN THE INSERTER WAS ATTACHED AND THE OPERATION WAS CHECKED BEFORE INSERTING IT, THE FIRST CAGE DID NOT EXTEND. AFTER REMOVING AND ATTACHING THE FIRST CAGE FROM/ TO THE INSERTER SEVERAL TIMES AND CHECKING THE OPERATION REPEATEDLY, IT EXTENDED SOMETIMES, BUT THE CONDITION DID NOT IMPROVE BECAUSE IT GOT STUCK IN THE MIDDLE OR IT DID NOT EXTEND UNLESS A CONSIDERABLE AMOUNT OF FORCE WAS APPLIED. THE FIRST CAGE WAS INSERTED INTO THE PATIENT'S BODY ONCE BUT IT DID NOT EXTEND WHEN AN ATTEMPT WAS MADE. THE FIRST CAGE DID NOT EXPAND PROPERLY. THEREFORE A NEW CAGE WAS TAKEN OUT. WHEN AN OPERATION CHECK WAS PERFORMED IN THE SAME WAY, THE SECOND CAGE EXTENDED SOMEWHAT, BUT STILL GOT STUCK IN THE MIDDLE OF EXTENSION. IT SUDDENLY BECAME CAPABLE OF EXTENSION WHEN IT WAS INSERTED INTO THE PATIENT'S BODY. THE INSTALLATION OF THE SECOND CAGE CAGE ITSELF WAS COMPLETED WITHOUT ANY PROBLEMS OR IMPACT TO THE PATIENT. THE INSERTER WAS SUSPECTED AS ONE POSSIBLE CAUSE. THE EVENT W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838799 ↗
• MalfunctionMar 3, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A CAGE IMPLANTED IN A PATIENT DURING A T12 SUBTOTAL REMOVAL, VERTEBRAL BODY REPLACEMENT FOR A BURST T12. IT WAS REPORTED THAT WHEN THE INSERTER WAS ATTACHED AND THE OPERATION WAS CHECKED BEFORE INSERTING IT, THE FIRST CAGE DID NOT EXTEND. AFTER REMOVING AND ATTACHING THE FIRST CAGE FROM/ TO THE INSERTER SEVERAL TIMES AND CHECKING THE OPERATION REPEATEDLY, IT EXTENDED SOMETIMES, BUT THE CONDITION DID NOT IMPROVE BECAUSE IT GOT STUCK IN THE MIDDLE OR IT DID NOT EXTEND UNLESS A CONSIDERABLE AMOUNT OF FORCE WAS APPLIED. THE FIRST CAGE WAS INSERTED INTO THE PATIENT'S BODY ONCE BUT IT DID NOT EXTEND WHEN AN ATTEMPT WAS MADE. THE FIRST CAGE DID NOT EXPAND PROPERLY. THEREFORE A NEW CAGE WAS TAKEN OUT. WHEN AN OPERATION CHECK WAS PERFORMED IN THE SAME WAY, THE SECOND CAGE EXTENDED SOMEWHAT, BUT STILL GOT STUCK IN THE MIDDLE OF EXTENSION. IT SUDDENLY BECAME CAPABLE OF EXTENSION WHEN IT WAS INSERTED INTO THE PATIENT'S BODY. THE INSTALLATION OF THE SECOND CAGE ITSELF WAS COMPLETED WITHOUT ANY PROBLEMS OR IMPACT TO THE PATIENT. THE INSERTER WAS SUSPECTED AS ONE POSSIBLE CAUSE. THE EVENT WAS AS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13658062 ↗