T2 STRATOSPHERE™ Expandable Corpectomy System 436013B (UDI 00643169663121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169663121), received between Jan 10, 2022 and Sep 23, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 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. How this data works · Data updated Oct 13, 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.

• 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 ↗
• InjuryDec 18, 2025Mechanical Problem; Migration; Mechanical Problem; Migration

  ADDITIONAL INFORMATION RECEIVED: THE PROCEDURE WAS AN ANTERIOR CERVICAL REVISION SURGERY- SPINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23836298 ↗
• MalfunctionJun 3, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING C4 CORPECTOMY FOR CERVICAL CORD COMPRESSION FROM DISC HERNIATION. IT WAS REPORTED THAT THE CAGE WAS PLACED ON THE INSERTER. WHEN SURGEON WAS READY TO IMPLANT, EXPANSION TRIAL WAS TESTED ALONG WITH TEMP LOCK FEATURE. THIS APPEARED TO WORK. HOWEVER, THE SURGEON WAS UNABLE TO TEMPORARILY LOCK THE EXPANSION. SURGEON AND THE NURSE THEN ATTEMPTED SEVERAL TIMES TO REASSEMBLE ON THE INSERTER TO TROUBLESHOOT WITH NO SUCCESS. SURGEON THEN TRIALED THE CAGE UP FROM THE 13B, THE 13MM C CAGE WHICH DID FUNCTION APPROPRIATELY, BUT HE WAS UNABLE TO USE AS ITS COLLAPSED HEIGHT WAS TOO LARGE FOR THE CORPECTOMY DEFECT. SURGERY THEN PROCEEDED WITH AN ALTERNATE CAGE TO COMPLETE THE PROCEDURE.  THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447873 ↗
• MalfunctionDec 26, 2023Manufacturing, Packaging or Shipping Problem; Mechanics Altered; Manufacturing, Packaging or Shipping Problem; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WOULD NOT LOCK IN THE EXPANDED POSITION AND THE LOCKING SET SCREW WOULD NOT TIGHTEN. SURGEON SWITCHED TO ANOTHER CAGE AND IT WORKED WITHOUT INCIDENT. 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 18391159 ↗
• MalfunctionMar 27, 2022Break; Activation Failure; Break; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT THE CAGE WOULD NOT PROPERLY EXPAND. THE SURGEON SPENT 40 MINUTES TRYING TO EXPAND THE DEVICE. THE DEVICE WOULD NOT FULLY OPEN AND CONTINUED TO COLLAPSE. AFTER FURTHER EXAMINATION WE DETERMINED ONE OF THE METAL TEETH ON THE DEVICE WAS BROKEN OFF. SURGEON USED THE NEXT SIZE LARGER CAGE AND IT EXPANDED PROPERLY AND WAS IMPLANTED. THERE WAS NO PATIENT SYMPTOM REPORTED. THE IMPLANT CAME IN CONTACT WITH PATIENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13925460 ↗
• MalfunctionFeb 8, 2022Material Deformation; Mechanics Altered; Noise, Audible; Material Deformation; Mechanics Altered; Noise, Audible

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH PRE-OP DIAGNOSIS- STENOSIS/TRAUMA INVOLVED IN THE ACDF/CORPECTOMY/STRATOSPHERE CAGE PROCEDURE. LEVELS IMPLANTED/TREATED C4-6 IT WAS REPORTED THAT INTRA-OPERATIVELY, IMPLANT WOULD NOT PROPERLY EXPAND AND MADE A RATCHETING NOISE. TEETH ON EXPANSION PORTION OF THE CAGE APPEAR TO BE DAMAGED AND RENDERED THE IMPLANT USE. IMPLANT WAS INSERTED INTO THE PATIENT AND THEN REMOVED. SURGEON SELECTED A DIFFERENT IMPLANT TO COMPLETE THE CASE. IT WAS BELIEVED THAT THE INSERTER DID NOT FULLY ENGAGE THE IMPLANT BEFORE EXPANSION. THERE WERE NO PATIENT SYMPTOMS REPORTED AS A RESULT OF THIS EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. PATIENT IS ALIVE AND NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13491604 ↗
• MalfunctionJan 10, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP OF THE REPORTED PRODUCT. THE PRE-OP DIAGNOSIS WAS MENTIONED AS STENOSIS. THE PROCEDURE PERFORMED WAS ACDF WITH CORPECTOMY. PATIENT MEDICAL HISTORY INCLUDES PARAPLEGIA. IT WAS REPORTED THAT, THE TOOTH ON WORM GEAR BROKE DURING EXPANSION. THE LEVELS IMPLANTED WERE C5. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT AND NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THE REPORTED PRODUCT CAME IN CONTACT WITH PATIENT. THERE WAS A DELAY OF 10 MINUTES REPORTED AS A RESULT OF PRODUCT MALFUNCTION. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13202946 ↗