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T2 STRATOSPHERE™ Expandable Corpectomy System 436020ARecalls & reported problems

Medtronic Sofamor Danek, Inc. · CENTERPIECE 436020A 20MM A-SIZE · Class 2 · Implant

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169663169), received between May 8, 2023 and May 8, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Mechanics Altered” (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

  • Mechanics Altered1

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.

  • MalfunctionMay 8, 2023Mechanics Altered; Mechanics Altered

    INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFATURING REPRESENTATIVE REAGARDING A PATIENT UNDERGOING AN ANTERIOR CORPECTOMY FOR A COLLAPSED VERTEBRAL BODY. IT WAS REPORTED THAT INSERTER ATTACHED TO CAGE AND WOULD EXPAND OUTSIDE OF PATIENT. ONCE INSERTED INTO PATIENT CAVITY AND IN PLACE OF VERTEBRAL BODY, WOULD NOT EXPAND OR ALLOW FOR EXPANSION AT ALL. REPLACED WITH AN ALTERNATIVE CAGE THAT ALLOWED EXPANSION. NO PATIENT SYMPTOMS REPORTED. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED DUE TO THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16884859 ↗

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