T2 STRATOSPHERE Expandable Corpectomy SystemRecalls & reported problems across all models
Medtronic Sofamor Danek, Inc. · 52 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 187
- Deaths reported
- 1
- Injuries reported
- 41
- Recalls
- 0
We found 52 models of T2 STRATOSPHERE Expandable Corpectomy System by Medtronic Sofamor Danek, Inc. in the FDA's device registry (GUDID). Together they are named in 187 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2018 and Sep 28, 2026 — classified as 1 death, 41 injuries, 145 malfunctions.
The most frequently reported specific device problem is “Mechanical Problem” (51 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported T2 STRATOSPHERE Expandable Corpectomy System problems
Device problems
- Mechanical Problem51
- Break36
- Mechanics Altered36
- Migration25
- Material Deformation22
- Activation Failure12
- Mechanical Jam8
- Migration or Expulsion of Device8
Patient problems
- No Clinical Signs, Symptoms or Conditions147
- No Known Impact Or Consequence To Patient22
- Bone Fracture(s)7
- Oversedation4
- Hemorrhage/Blood Loss/Bleeding3
- Peripheral Nervous Injury3
- Pain2
- Confusion/ Disorientation1
T2 STRATOSPHERE Expandable Corpectomy System models
52 models, most reported first. Each model has its own page with its reports, recalls and device details.
- T2 STRATOSPHERE Expandable Corpectomy System 436120CSpinal vertebral body replacement device23 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013BSpinal vertebral body replacement device14 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360113Spinal vertebral body replacement device13 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013CSpinal vertebral body replacement device11 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013BSpinal vertebral body replacement device7 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025CSpinal vertebral body replacement device7 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013CSpinal vertebral body replacement device7 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436113BSpinal vertebral body replacement device6 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436120450Spinal vertebral body replacement device6 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020DSpinal vertebral body replacement device1 death6 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013ASpinal vertebral body replacement device6 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436113CSpinal vertebral body replacement device5 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013DSpinal vertebral body replacement device5 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436120BSpinal vertebral body replacement device4 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360258Spinal vertebral body replacement device4 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360113Spinal vertebral body replacement device4 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436113DSpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436120DSpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013ASpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020CSpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025DSpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013DSpinal vertebral body replacement device3 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System NAV4360113Orthopedic stereotaxic instrument2 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436120ASpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE Expandable Corpectomy System 436120400Spinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360208Spinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013ESpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020BSpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025ASpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025BSpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360120Spinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020CSpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020DSpinal vertebral body replacement device2 reports
- T2 STRATOSPHERE™ Expandable Corpectomy System NAV4360221Orthopedic stereotaxic instrument1 report
- T2 STRATOSPHERE Expandable Corpectomy System 436125BSpinal vertebral body replacement device1 report
- T2 STRATOSPHERE Expandable Corpectomy System 436125CSpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360250Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360300Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360308Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020400Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020450Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025300Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020ASpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436020ESpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360221Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360138Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360258Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436013ESpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025BSpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 436025CSpinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4369225Spinal vertebral body replacement device1 report
- T2 STRATOSPHERE™ Expandable Corpectomy System 4360413Spinal vertebral body replacement device1 report
Recent T2 STRATOSPHERE Expandable Corpectomy System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Mechanical Problem
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a cage used for Spinal therapy. It was reported that the cage would not provisionally lock. There were no patient symptoms reported. There were no further complications reported regarding the event. Additional information received that the procedure involved was Anterior Cervical Discectomy and Fusion.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50911737 ↗MalfunctionSep 25, 2026Mechanical Problem; Material Deformation
Information was received from healthcare provider (HCP) via a manufacturer representative regarding a patient having Spinal therapy. It was reported that, upon attempting to secure and lock the expanded mesh construct into its final position, the internal locking screw mechanism failed. The threads stripped continuously, preventing proper torque delivery and complete locking/fixation. The primary defective expandable mesh cage was removed and discarded. A replacement implant of the same size was opened, deployed, and locked successfully. The surgical procedure was completed successfully without further delay or patient injury. Procedure performed was corpectomy requiring structural interbody reconstruction. There were no patient symptoms reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50894453 ↗MalfunctionSep 25, 2026Mechanical Problem
Information was received from user facility via a manufacturer representative regarding a device used for Corpectomy at level C6. It was reported that the locking ring was difficult to move and the inserter was also difficult to remove when testing fit and function when loading and removing the implant. There was no patient involvement reported. There were no further complications reported regarding the event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50893798 ↗MalfunctionSep 23, 2026Mechanical Problem; Material Deformation
Information was received from Distributor via a manufacturer representative regarding a Patient having C3-5 corpectomy requiring str uctural interbody reconstruction. It was reported that during the procedure, a expandable mesh cage was positioned and expanded in accordance with the manufacturer's technical manual. During attempted final locking of the expanded mesh construct, the internal locking screw mechanism failed, and the locking screw threads stripped continuously, preventing proper torque delivery and complete locking and fixation in the final position. The expandable mesh cage was explanted, removed, and discarded. A same-size replacement implant was deployed and successfully locked. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50865556 ↗MalfunctionMay 26, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE PROVISIONAL LOCKING MECHANISM WAS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25273601 ↗MalfunctionMay 18, 2026Break; Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER WAS BROUGHT TO THE FACILITY FOR PRE OPERATIVE DECONTAMINATION AND AFTER DECONTAMINATING THE PRIMARY STRUCTURAL SECURITY SCREW WAS FOUND TO BE MISSING, LEAVING THE INSERTER USELESS. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED AS THE INSERTER HAS BEEN USED BEFORE IN CASES WITHOUT ANY MALFUNCTIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25197337 ↗MalfunctionMay 15, 2026Material Deformation
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CENTERPIECE SET SCREW WAS STRIPPED. IT WAS ALSO REPORTED THAT AN END CAP WAS ATTACHED TO THE IMPLANT AT THE TIME OF IMPLANTING. IT WAS FURTHER REPORTED THAT AN END CAP BROKE WHILE BEING REMOVED FROM THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25182065 ↗MalfunctionApr 14, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CENTERPIECE SET SCREW WAS STRIPPED. IT WAS ALSO REPORTED THAT AN END CAP WAS ATTACHED TO THE IMPLANT AT THE TIME OF IMPLANTING. IT WAS FURTHER REPORTED THAT AN END CAP BROKE WHILE BEING REMOVED FROM THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872235 ↗MalfunctionApr 9, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CENTERPIECE SET SCREW WAS STRIPPED. IT WAS ALSO REPORTED THAT AN END CAP WAS ATTACHED TO THE IMPLANT AT THE TIME OF IMPLANTING. IT WAS FURTHER REPORTED THAT AN END CAP BROKE WHILE BEING REMOVED FROM THE IMPLANT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24834752 ↗MalfunctionApr 8, 2026Break
INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A PRODUCT USED FOR SPINAL THER APY. IT WAS REPORTED THAT THE DEVICE WAS BROKEN. THERE WAS NO PATIENT INVOLVED AND NO FURTHER COMPLICATIONS OR SYMPTOMS REPORTED REGARDING THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24813385 ↗MalfunctionApr 7, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING MULTIPLE INSTRUMENTS. IT WAS REPORTED THAT DURING FIELD CONTACT, THE FOLLOWING DEVICE-RELATED ISSUES AND MALFUNCTIONS WERE IDENTIFIED: THE SLEEVE 7967028 INSERTER WOULD NOT ATTACH WITH TRIAL, THE SHAFT 2161001 OLIF25 INTERBODY THREADED HAD A TIP THAT BROKE OFF, THE INSERTER 4360113 13MM INSERTER CASE WAS NOT ATTACHING, AND THE DRIVER 6630904 T8/T10 DRIVER WAS STRIPPED. TIP BROKE OFF FOR INSERTER 6279002 PSR ENDCAP THREADED. DRIVER 7080907 2.5 HEX SCREWDRIVER (QTY-2) WERE STRIPPED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24804952 ↗MalfunctionMar 25, 2026Mechanical Problem
INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE INSERTER EXPERIENCED ISSUES INCLUDING A SCREW LOST FROM THE INSERTER, OTHER SCREWS BEING LOOSE BUT REMAINING IN THE INSTRUMENT, AND SCREWS FALLING OUT DURING STERILIZATION. THERE WAS NO PATIENT. NO FURTHER COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24684097 ↗MalfunctionMar 14, 2026Detachment of Device or Device Component
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING AN EVENT. IT WAS REPORTED THAT DRIVER STRIPPED AND CENTERPIECE MIDDLE SET SCREW FELL OUT. NO PATIENT INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24600008 ↗MalfunctionMar 13, 2026Break
INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CONNECTION PRONGS AT THE END OF THE INSERTER BENT AND SNAPPED OFF CAUSING THE INSERTER TO NO LONGER BE OF USE AND ONE OF THE ARMS OF THE REMOVAL TOOL SNAPPED OFF. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE TYPE OF PROCEDURE INVOLVED DURING THE INCIDENT WAS A CORPECTOMY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24588007 ↗MalfunctionMar 12, 2026Break
INFORMATION WAS RECEIVED FROM USER FACILITY VIA MANUFACTURING REPRESENTATIVE REGARDING A PRODUCT IDENTIFIED DURING SERVICING. IT WAS REPORTED THAT THE INSERTER WAS BROKEN. NO PATIENT WAS INVOLVED IN THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24578798 ↗
Other Medtronic Sofamor Danek, Inc. products
- CD HORIZON Spinal System342 models · 2,323 reports
- GRAFTONand GRAFTON PLUSDemineralized Bone Matrix (DBM)25 models · 12 reports · 14 recalls
- METRx System5 models · 672 reports
- INFUSE Bone Graft6 models · 576 reports · 1 recall
- CD HORIZON SOLERA VOYAGER Spinal System60 models · 411 reports
- POWEREASE Instruments8 models · 331 reports · 1 recall
- Catalyft PL Expandable Interbody System16 models · 279 reports · 1 recall
- INFINITY Occipitocervical Upper Thoracic System35 models · 63 reports · 5 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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