T2 STRATOSPHERE™ Expandable Corpectomy System 436020C (UDI 00763000856311)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 436020C 20MM C-SIZE · Class 2 · Implant
All models of T2 STRATOSPHERE Expandable Corpectomy System (52)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- 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 00763000856311), received between May 15, 2025 and Jan 16, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem2
- Mechanical Jam1
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.
MalfunctionJan 16, 2026Mechanical Problem; Mechanical Jam
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR CORPECTOMY PROCEDURE IT WAS REPORTED THAT THE SURGEON IMPACTED THE IMPLANT INTO THE SURGICAL SITE. HOWEVER, DURING THE SUBSEQUENT ATTEMPT TO DISTRACT THE DEVICE, THE EXPANSION MECHANISM FAILED TO ENGAGE. DESPITE MULTIPLE ATTEMPTS, THE IMPLANT REMAINED STUCK/JAMMED AND COULD NOT BE DISTRACTED. CONSEQUENTLY, THE MALFUNCTIONING IMPLANT WAS REMOVED AND REPLACED WITH A NEW IMPLANT OF THE SAME SIZE. THE SECOND IMPLANT FUNCTIONED CORRECTLY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. 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 24092482 ↗MalfunctionMay 15, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT H AVING CORPECTOMY SPINAL THERAPY. IT WAS REPORTED THAT THE IMPLANT COLLAPSED AND COULD NOT EXPAND COMPLETELY WHEN INSERTED INTO THE VERTEBRAE BODY. THE SURGEON REPLACED IT WITH ANOTHER IMPLANT OF THE SAME SIZE, SUCCESSFULLY COMPLETED THE SURGERY. NO PATIENT SYMPTOMS OR COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE LEVELS INVOLVED DURING THE EVENT WAS L2-L3.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22024225 ↗
Other Spinal vertebral body replacement device devices
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- X-CORE 7220018Nuvasive, Inc. · 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
- GIZA Corpectomy implant Giza, Diam 14 mm, 23-32 mm, 7-10 DegEden Spine Europe SA · Spinal Vertebral Body Replacement Device1 recall0 reports
- X-CORE 7160012Nuvasive, 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 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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