T2 STRATOSPHERE™ Expandable Corpectomy System 4360113 (UDI 00763000864866)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · INSERTER 4360113 13MM INSERTER · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000864866), received between Apr 24, 2025 and Mar 12, 2026 — classified as 4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Mechanical Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 12, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN INTO PIECES. THERE WAS NO PATIENT INVOLVEMENT REPORTED AND NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577979 ↗MalfunctionMar 12, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS NOT CONNECTING TO THE CAGE AND EXPANDING. THERE WERE NO PATIENT SYMPTOMS/COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24577459 ↗MalfunctionMar 11, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REP ORTED THAT, THE SCREWDRIVER DOES NOT SEAT INTO HANDLE. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566736 ↗MalfunctionApr 24, 2025Break; Break
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED PRIOR TO USE. IT WAS REPORTED THAT THE SCREW BROKE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21898076 ↗
Other Spinal vertebral body replacement device devices
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- 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.