T2 STRATOSPHERE™ Expandable Corpectomy System 436025ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169663213), received between Apr 14, 2020 and Jul 17, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 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.

• 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 22529196 ↗
• MalfunctionApr 14, 2020Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4 BURST FRACTURE, WHICH OCCURRED SOME TIME AGO. HE UNDERWENT L4 CORPECTOMY AND FUSION. INTRA-OP, AFTER INSERTING THE IMPLANT INTO THE POSITION, A CRACK LIKE SOUND WAS HEARD WHILE IT WAS BEING EXPANDED. THE TEETH ON THE CAGE HAD BROKEN, WHICH PREVENTED THE EXPANSION MECHANISM FROM WORKING. IT WAS DETERMINED THAT THE EXPANSION DRIVER BROKE THE TEETH OF THE IMPLANT. AS THE IMPLANT FAILED TO EXPAND, IT WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9956473 ↗