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T2 STRATOSPHERE™ Expandable Corpectomy System 4360308Recalls & reported problems

Medtronic Sofamor Danek, Inc. · ENDCAP 4360308 30MM 8 DEGREE · Class 2 · Implant

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169651029), received between Jul 18, 2022 and Jul 18, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Migration” (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

Device problems

  • Migration1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 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 FR

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15037666 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.