T2 STRATOSPHERE™ Expandable Corpectomy System 436020BRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169663176), received between Jun 15, 2021 and Dec 14, 2023 — 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 16, 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.

• MalfunctionDec 14, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT CAGE COULD NOT BE OPENED DURING SURGERY.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18324916 ↗
• MalfunctionJun 15, 2021Mechanical Jam; Mechanics Altered; Mechanical Jam; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A CENTERPIECE AND INSERTER USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS FRACTURE LWS1. PROCEDURE PERFORMED IN THE EVENT WAS VERTEBRAL BODY REPLACEMENT. IT WAS REPORTED THAT INTRA-OPERATIVELY, THE IMPLANT WAS INSERTED, A CORRECTION TO THE BONE WAS NECESSARY SO THAT THE IMPLANT WAS REMOVED AGAIN, REINSERTION WAS NO LONGER POSSIBLE BECAUSE THE IMPLANT COULD NO LONGER BE DISTRACTED AND NO LONGER HELD FIRMLY TO THE INSERTER. DURING FIRST INSERTION, THE INSERTER AND IMPLANT FUNCTIONED WITHOUT ANY PROBLEMS, AND PRELIMINARY DISTRACTION WITH A RING ON THE INSERTER WAS ALSO PROBLEM-FREE. SINCE REWORKING OF THE BONE WAS REQUIRED, THE IMPLANT WAS REMOVED AGAIN. AFTER THAT, IT COULD NO LONGER BE EXTRACTED, AND IT WAS STUCK. IN ADDITION, IT NO LONGER SAT PROPERLY ON THE INSERTER. IT IS UNCLEAR WHETHER THE INSERTER BENT WHEN THE IMPLANT WAS REMOVED AFTER THE FIRST TEMPORARY INSERTION. THE PRODUCTS CAME IN CONTACT WITH PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS NO TREATMENT OR ADDITIONAL SURGERY PERFORMED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11997489 ↗