T2 STRATOSPHERE™ Expandable Corpectomy System 436025300Recalls & reported problems
Medtronic Sofamor Danek, Inc. · ENDCAP 436025300 EXTNDED 25 X 30MM 0 DEG · Class 2 · Implant
All models of T2 STRATOSPHERE Expandable Corpectomy System (52)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00643169651074), received between Nov 4, 2025 and Nov 4, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Mechanical Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
- Product Quality Problem1
Patient problems
- Oversedation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 4, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING PRODUCTS USED IN SPINAL THERAPY. IT WAS REPORTED THAT DURING A SPINAL PROCEDURE, THE CAGE WOULD NOT EXPAND FULLY AND WOULD NOT COLLAPSE FULLY, AND THE ENDCAP WOULD ONLY ATTACH ON ONE SIDE AND KEPT FALLING OFF. THESE ISSUES ADDED CONSIDERABLE TIME TO THE OPERATION, EXPOSING THE PATIENT TO MULTIPLE PASSES OF INSTRUMENTATION PAST NERVE ROOTS AND UNNECESSARY EXPOSURE TO ANESTHETIC. BOTH PRODUCTS WERE EXPLANTED IN SAME SURGERY. THERE WERE NO FURTHER PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE PROVISIONAL LOCKING RING ON THE INSERTER LOCKS THE GRUB SCREW ON THE CENTER STRUT. PRE-OP DIAGNOSIS OF PATIENT WAS L3 BURST FRACTURE, PROCEDURE INVOLVED IN THE EVENT WAS L3 CORPECTOMY, LEVELS IMPLANTED WAS L3 AND THERE WERE NO PATIENT COMPLICATION TO NOTE BUT IT DID ADD 90 MINS TO THE SURGERY.
Patient problems: Oversedation
MAUDE report 23463908 ↗
Other Spinal vertebral body replacement device devices
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- X-CORE 7160012Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7220018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7160014Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180018Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- X-CORE 7180016Nuvasive, Inc. · SPINAL VERTEBRAL BODY REPLACEMENT DEVICE1 recall0 reports
- GIZA Corpectomy implant Giza, Diam 14 mm, 18-22 mm, 2-5 DegEden Spine Europe SA · 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
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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