T2 STRATOSPHERE™ Expandable Corpectomy System 436025C (UDI 00643169663237)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169663237), received between Dec 29, 2020 and Nov 4, 2025 — classified as 5 injuries, 2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 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 23463832 ↗
• InjurySep 11, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A CORPECTOMY PROCEDURE IN A PATIENT DIAGNOSED WITH TUMOR. IT WAS REPORTED THAT THE PROSTHETIC VERTEBRAL BODY LOOSENED AND MIGRATED. THE CAGE AND ENDCAP WERE EXPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE E VENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23028759 ↗
• InjuryApr 30, 2024Break; Break

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PROCEDURE FOR L1 LATERAL CORPECTOMY (REPLACEMENT OF VERTEBRAL BODY WITH EXPANDABLE CAGE). IT WAS REPORTED THAT THE IMPLANT APPEARED TO HAVE BROKEN TEETH ON THE EXPANDABLE ELEMENT, WHICH STOPPED THE IMPLANT FROM BEING USED IN A NORMAL FASHION. IMPLANT WOULD NOT RAISE TO REQUIRED HEIGHT AND ON INSPECTION AND EXPLANT, SEEMED TO BE DEFECTIVE. THIS IMPLANT WAS REPLACED BY ANOTHER, SMALLER IMPLANT. THERE WAS NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19210826 ↗
• MalfunctionDec 1, 2023Device Slipped; Material Twisted/Bent; Mechanical Jam; Device Slipped; Material Twisted/Bent; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE ROTATION AND EXPANSION PROCESS, SLIPPED APPEAR, THEN IT GOT STUCK. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18244138 ↗
• InjurySep 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTEROLATERAL C ORPECTOMY FOR BURST FRACTURE. LEVELS IMPLANTED: L4 IT WAS REPORTED THAT THAT DEVICES BROKE AND WERE EXPLANTED. NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. IMMEDIATELY POST OP, THE PATIENT WAS NEUROLOGICALLY INTACT. HOWEVER, AFTER UNDERGOING PHYSICAL THERAPY, THE PATIENT DEVELOPED SOME NEUROLOGICAL DEFICIT IN THE LEFT LOWER EXTREMITY. THE PATIENT WAS BROUGHT BACK IN FOR IMAGING AND THE INSTRUMENTATION WAS INTACT. IT WAS THE SURGEONS BELIEF THAT THE PATIENT HAS DEVELOPED A PALSY DUE TO THE EXTENDED RETRACTION ON THE PSOAS MUSCLE. ONE OF THE CONTRIBUTING FACTORS IN THE AMOUNT OF TIME THE PSOAS WAS UNDER RETRACTION WAS DUE TO THE ISSUES WITH THE EXPANDABLE CORPECTOMY DEVICE. THESE ISSUES INCREASED THE AMOUNT OF TIME IT TOOK TO COMPLETE THE CORPECTOMY BY ABOUT AN HOUR. ALL THREE DEVICES CONTRIBUTED TO THE DELAY: THE EXTRA TIME TO REMOVE AND THEN ATTEMPT TO RESNAP THEM BACK ON, ETC. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 15436816 ↗
• InjuryMar 4, 2021Naturally Worn; Activation Failure; Naturally Worn; Activation Failure

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF TUMOR OF L5 WHICH REQUIRED L5 CORPECTOMY AND FUSION. IT WAS REPORTED THAT INTRA-OP, THE IMPLANT WAS PLACED IN THE L5 CAVITY WHERE THE CORPECTOMY WAS PERFORMED. THE CAGE WAS THEN EXPANDED IN-SITU. ONCE THE CAGE ENGAGED THE L4/ S1 END PLATES THE RATCHET MECHANISM STARTED SLIPPING AND THEREFORE THE CAGE WOULD NOT EXPAND ENOUGH. THE TEETH INSIDE THE CENTREPIECE BECAME WORN AND FLAT. THEREAFTER THE CAGE WOULD NOT EXPAND OR COLLAPSE WHEN TURNING THE HANDLE ON THE INSERTER. THE ADJUSTABLE ENDPLATE ON THE CENTERPIECE WAS ADJUSTED, TORQUED AND LOCKED TO A LORDOTIC ANGLE AND BEFORE CAGE INSERTION. THIS ANGLE WAS LOST EVERY TIME THE CAGE WAS EXPANDED IN-SITU. THIS HAPPENED TO BOTH REPORTED CENTERPIECES. ALTHOUGH THE ENDCAPS WERE ATTACHED TO THE CAGES, NO FAULT TO THE END CAPS NOTED. ONLY THE CENTERPIECES WERE FAULTY. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PROCEDURE RESULTED IN LONGER THEATRE AND ANESTHETIC TIME AND INCREASED BLOOD LOSS. THERE WAS DELAY OF 90 MINUTES IN OVERALL PROCEDURE TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Oversedation

  MAUDE report 11410560 ↗
• MalfunctionDec 29, 2020Material Deformation; Mechanical Jam; Material Deformation; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURING REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION FOR SPINAL THERAPY. EVENT OCCURRED INTRA-OP. IT WAS REPORTED THAT ISSUE OCCURRED WHILE ATTEMPTING TO IMPLANT THE DEVICE. THE IMPLANT WAS CORRECTLY LOADED ONTO THE INSERTER, AND WHILE IMPLANT WAS COLLAPSED, BIOLOGIC WAS PACKED INTO THE CENTER OF THE CAGE. OSTEOCELL AND IFACTOR MIXED TOGETHER FOR BIOLOGICS. WHILE INSERTING, IT WAS ATTEMPTED TO EXPAND THE IMPLANT AND SEEMED TO JAM. IT WAS ATTEMPTED TO ROTATE T-HANDLE INSERTER TO EXPAND, AND IT CONTINUED TO JAM. IMPLANT WAS TAKEN OUT AND CLEANED TEETH AND ROTATING MECHANISM. BIOLOGICS GOT CAUGHT IN THE TEETH AND JAMMED IT. AFTER MANY ATTEMPTS TO CLEAN OUT THE BIOLOGIC AND GET IT TO EXPAND, IT CONTINUED TO JAM. ON CLOSER INSPECTION, WHEN IT JAMMED, 2 TEETH OF THE EXPANSION MECHANISM HAD SHEERED OFF, AND IT WOULD NOT EXPAND WITHOUT THOSE. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS REPORTED. DEVICE WILL BE RETURNED. UPDATE; PROCEDURE WAS L4 CORPECTOMY, APPROACHED ANTERIOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086072 ↗