T2 STRATOSPHERE™ Expandable Corpectomy System 436020C (UDI 00643169663183)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 436020C 20MM C-SIZE · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169663183), received between Mar 12, 2020 and Jul 28, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Activation 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem1
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 28, 2025Mechanical Problem; Mechanical Problem
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING VERTEBRECTOMY S PINAL THERAPY FOR COMPRESSION FRACTURE. LEVELS IMPLANTED WERE T9/10. IT WAS REPORTED THAT THE STRATOSPHERE GRAFT WOULD NOT EXPAND. THE PRODUCT WAS EXPLANTED, AND A NEW CENTERPIECE WAS IMPLANTED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22635376 ↗MalfunctionJul 26, 2022Activation Problem; Activation Problem
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A CENTERPIECE USED FOR SPINAL SURGERY. PRE-OP DIAGNOSIS WAS CANCER. PROCEDURE PERFORMED IN THE EVENT WAS CORPECTOMY. IT WAS REPORTED THAT INTRA-OPERATIVELY, CAGE CLICKING AND NOT EXPANDING PROPERLY. THE PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS A DELAY OF 3 MINUTES IN THE OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15101063 ↗MalfunctionMar 12, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT LATERAL CORPECTOMY SURGERY AT L2 DUE TO INFECTION. INTRA-OP, THE CAGE WOULD NOT HOLD THE DESIRED HEIGHT EVEN AFTER THE LOCKING SCREW WAS TORQUED. AS PER THE SURGEON THE LOCKING SCREW WAS STRIPPED OR THE INNER THREADS ON THE CAGE WHICH ACCEPT THE LOCKING SCREW WAS STRIPPED. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9822192 ↗
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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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