T2 STRATOSPHERE™ Expandable Corpectomy System 4360208Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169650930), received between Mar 16, 2022 and Mar 16, 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 16, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE END CAP WAS SNAPPED ONTO THE EXPANDABLE DEVICE BUT WAS IN A SUBOPTIMAL ORIENTATION FOR IMPLANTATION. THEREFORE, IT WAS NECESSARY TO REMOVE THE END CAP AND REAPPLY IT BUT END CAP COULD NOT BE REMOVED DESPITE MULTIPLE ATTEMPTS USING THE TOOL. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE SURGEON ATTEMPTED TO IMPLANT THEM BUT IT WAS OBVIOUS THAT THE ORIENTATION WAS INCORRECT AND THE ATTEMPTS WERE ABORTED PRETTY QUICKLY. THERE IS NO MALFUNCTION WITH THE CAGE BUT IT MIGHT BE A POORLY DESIGNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790310 ↗
• MalfunctionMar 16, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT FOR UNKNOWN SPINAL THE RAPY. IT WAS REPORTED THAT THE END CAP WAS SNAPPED ONTO THE EXPANDABLE DEVICE BUT WAS IN A SUBOPTIMAL ORIENTATION FOR IMPLANTATION. THEREFORE, IT WAS NECESSARY TO REMOVE THE END CAP AND REAPPLY IT BUT END CAP COULD NOT BE REMOVED DESPITE MULTIPLE ATTEMPTS USING THE TOOL. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE SURGEON ATTEMPTED TO IMPLANT THEM BUT IT WAS OBVIOUS THAT THE ORIENTATION WAS INCORRECT AND THE ATTEMPTS WERE ABORTED PRETTY QUICKLY. THERE IS NO MALFUNCTION WITH THE CAGE BUT IT MIGHT BE A POORLY DESIGNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13790263 ↗