T2 STRATOSPHERE Expandable Corpectomy System 436120DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169634879), received between Oct 13, 2021 and Feb 3, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAGE IN A VERTEBRAL BODY REPLACEMENT FOR A T1/2 VERTEBRAL FRACTURE AT L1 AND L2. IT WAS REPORTED THAT WHEN ATTEMPTING TO JACK UP THE CAGE, IT BECAME DIFFICULT TO MOVE AND STOPPED MOVING. THE OPERATION WAS REPLACED WITH ANOTHER IMPLANT, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THE PRODUCT WAS USED ON THE PATIENT AND THE PATIENT WAS ON THE OPERATING TABLE WHEN THE MALFUNCTION OCCURRED. THERE WAS A LESS THAN60 MINUTE DELAY IN THE OVERALL PROCEDURE TIME. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16289434 ↗
• MalfunctionOct 15, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT, THE CAGE WAS INSERTED AND TAKEN OUT AGAIN FOR MORE BONY WORK ON SITE. NEW INSERTION TOOK PLACE AND THE RING MUST HAVE BEEN TURNED WHILE TAKING OUT. THE CAGE WAS A LITTLE BLOCKED, THE SURGEON KEPT DISTRACTING AND THE GEAR IN CAGE BROKE. THE CAGE WAS REPLACED BY NEW IN SAME SIZE. THE THERAPY ASSOCIATED WITH THE REPORTED EVENT WAS CORPECTOMY. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED. NO ADDITIONAL TREATMENT OR SURGERY PERFORMED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612509 ↗
• MalfunctionOct 13, 2021Break; Activation Problem; Break; Activation Problem

  THE INFORMATION WAS RECEIVED FROM HEALTH CARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT FOR SPINAL THERAPY. IT WAS REPORTED THAT SOME TEETH OF THE CAGE BROKE DURING THE SURGERY. THE CAGE COULDN´T BE EXPANDED DURING THE SURGERY. THE DELAY IN PROCEDURE WAS ABOUT 20 MINUTES IN ORDER TO CHANGE THE IMPLANT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12621500 ↗