T2 STRATOSPHERE™ Expandable Corpectomy System 436020D (UDI 00763000856328)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 436020D 20MM D-SIZE · Class 2 · Implant
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000856328), received between Dec 10, 2024 and Feb 10, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 10, 2025Break; Break
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR REGARDING AN IMPLANT TO BE USED IN CORPECTOMY. IT WAS REPORTED THAT THE IMPLANT WAS BROKEN. THE PROBLEM WAS IDENTIFIED DURING UNPACKING INSPECTION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341412 ↗MalfunctionDec 10, 2024Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPI NAL THERAPY FOR VERTEBRAL COLLAPSE. IT WAS REPORTED THAT A D-SIZE PROSTHESIS WAS IMPLANTED. AFTER IMPLANTATION, IT WAS FOUND THAT THE VERTEBRAL BODY WAS OVER-SUPPORTED. THE PROSTHESIS WAS THEN REMOVED. AFTER REMOVAL, IT WAS FOUND THAT THE SLIDING COVER WAS IMMOBILE. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20890183 ↗
Other Spinal vertebral body replacement device devices
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- X-CORE 7220016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 2-5 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 33-54 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 5-8 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.