T2 STRATOSPHERE™ Expandable Corpectomy System 436025B (UDI 00643169663220)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169663220), received between Jul 17, 2025 and May 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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.

• MalfunctionMay 15, 2026Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CENTERPIECE SET SCREW WAS STRIPPED. IT WAS ALSO REPORTED THAT AN END CAP WAS ATTACHED TO THE IMPLANT AT THE TIME OF IMPLANTING. IT WAS FURTHER REPORTED THAT AN END CAP BROKE WHILE BEING REMOVED FROM THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25182065 ↗
• MalfunctionJul 17, 2025Mechanical Problem; Problem with Sterilization; Material Deformation; Mechanical Problem; Problem with Sterilization; Material Deformation

  INFORMATION WAS RECEIVED FROM USER FACILITY (UF) VIA MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED FOR SPINAL THERAPY. IT WAS REPORTED THAT PRIOR TO THE CASE, BOTH IMPLANTS WOULD NOT PROPERLY LOAD ONTO MULTIPLE INSERTERS, INCLUDING BOTH NON-NAVIGATED AND NAVIGATED INSERTERS. THE IMPLANTS WERE DESCRIBED AS WOBBLING AND WOULD NOT EXPAND AND CONTRACT PROPERLY. THE CENTER SCREWS ON BOTH IMPLANTS APPEARED TO BE STRIPPED, AND BOTH IMPLANTS HAD A SMALL AMOUNT OF BIO PRESENT. BOTH IMPLANTS WERE NEVER IMPLANTED. THERE WAS NO PATIENT INVOLVED REPORTED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE ISSUE WAS NOT A MANUFACTURING ISSUE. THE STRIPPED SCREWS ARE A COMPONENT OF THE IMPLANT. THEY ARE NOT A SEPARATE ITEM/PRODUCT FROM THE CAGE. THERE WAS A LITTLE MANUFACTURED BONE INSIDE OF THE CAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529215 ↗