T2 STRATOSPHERE™ Expandable Corpectomy System 436025DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169663244), received between Sep 19, 2019 and Jul 18, 2022 — classified as 1 injury, 2 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.

• InjuryJul 18, 2022Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING L5 CORPECTOMY F ROM AN ANTERIOR APPROACH. IT WAS REPORTED THAT STRATOSPHERE CAGE WAS PLACED WITH A PYRAMID 3 HOLE PLATE PLACED AT THE PROMONTORY OF S1. AFTER THIS STAGE PATIENT WAS FLIPPED TO PRONE AND A L2-IL PROCEDURE WAS PERFORMED USING SOLERA MAS SCREWS AND BALLAST CMAS SCREWS. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED : PRE-OP DIAGNOSIS/MEDICAL HISTORY: L5 BURST FRACTURE PROCEDURE INVOLVED: L5 CORPECTOMY WITH EXPANDABLE CAGE PLACEMENT FROM L4 ENDPLATE TO S1 ENDPLATE. PLATE IMPLANTED ANTERIORLY AT S1. THE EXPOSURE SURGEON IN THE ROOM FOR THE REMOVAL NOTED THE PATIENT ACKNOWLEDGED A FALL AFTER SURGERY (TIMEFRAME UNKNOWN). THE FRONT OF S1 BROKE OFF CAUSING THE PLATE AND 2 SCREWS TO BREAK OFF THE BONE. THE CAGE ALSO KICKED OUT ANTERIORLY AFTER THIS INCIDENT AND AT THIS POINT WAS NOT ADDING ANY STRUCTURAL SUPPORT TO THE CONSTRUCT. THE PATIENT HAD POSTERIOR HARDWARE IN WHICH ALL STAYED INTACT. AFTER THE FRACTURE AT S1 AND THE HARDWARE KICKED OUT ANTERIORLY THE PATIENT WAS NO LONGER STRUCTURALLY SUPPORTED UP F

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15037661 ↗
• MalfunctionJul 8, 2021Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING PATIENT FOR UNKNOWN SPINAL THERA PY. IT WAS REPORTED THAT DURING EXPANSION OF CAGE THE INTERNAL GEAR ON THE CAGE ITSELF BROKE AND WOULD NOT ALLOW FOR MORE EXPANSION. THERE WAS NO HARM TO PATIENT, SIMPLY NEED TO REPLACE THAT BROKEN CAGE. THERE WERE NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. 2021-JUL-01_E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THERE WAS ABOUT AT LEAST 15MINS OR MORE THAT PROBABLY GOT ADDED TO THE SURGERY DUE TO NEEDING TO SWITCH FROM STRATOSPHERE TO ALTITUDE THAT INCREASED THE OVERALL PROCEDURE TIME. THIS WAS CAUSED BY THE INTERNAL GEAR IN THE CAGE BROKE THAT WOULD ONLY ALLOW THE CAGE TO EXTEND UP ABOUT HALF WAY. THERE WAS NO HARM TO THE PATIENT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134400 ↗
• MalfunctionSep 19, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT INTRA-OP, INITIAL THREADS OF THE IMPLANT STRIPPED AND SHEARED, WHICH DID NOT ALLOW CAGE TO EXPAND. THE IMPLANT WAS THEN COMPLETELY EXPLANTED; AND WAS REPLACED BY ANOTHER PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9085377 ↗