T2 STRATOSPHERE™ Expandable Corpectomy System 436013E (UDI 00643169663152)Recalls & reported problems
Medtronic Sofamor Danek, Inc. · CENTERPIECE 436013E 13MM E-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 00643169663152), received between Dec 28, 2020 and May 14, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Activation Failure” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Failure1
- Material Deformation1
- 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.
MalfunctionMay 14, 2025Mechanical Problem; Mechanical Problem
ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE SET SCREWS WOULD NOT TURN, NOT ALLOWING THE CAGE TO LOCK INTO PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22016395 ↗MalfunctionDec 28, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure
INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE REGARDING A PATIENT WHO UNDERGONE SPINAL THERAPY WITH UNKNOWN INDI CATION. IT WAS REPORTED THAT DURING INTRA-OP WHILE INSERTING EXPANDABLE CAGE, CAGE WOULD NOT STAY EXPANDED. POSSIBLE THAT CAGE SCREW STRIPPED OR INSERTED IS STRIPPED. CENTERPIECE WOULD NOT STAY EXPANDED AND END CAP ATTACHED TO THE CENTERPIECE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT TYPE OF PROCEDURE PERFORMED WAS T3-5 CORPECTOMY/TUMOR REMOVAL (POSTERIOR APPROACH). THE REPORTED PRODUCTS COME IN CONTACT WITH PATIENT. NO SPECIFIC MALFUNCTION REPORTED FOR THE ENDCAPS BUT ATTACHED WITH CENTERPIECE. NO FURTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11085370 ↗
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- 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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