T2 STRATOSPHERE™ Expandable Corpectomy System 436013C (UDI 00763000856267)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000856267), received between Mar 12, 2025 and Sep 25, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (4 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 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 ↗
• MalfunctionJan 20, 2026Mechanics Altered

  INFORMATION WAS RECEIVED FROM VARIOUS SOURCES REGARDING A PATIENT UNDERWENT A CERVICAL CORPECTOMY PROCEDURE FOR SPINAL TUMOR. IT WAS REPORTED THAT AFTER SELECTING THE APPROPRIATE SIZE, THE SURGEON IMPACTED THE IMPLANT INTO THE SURGICAL SITE. HOWEVER, DURING ATTEMPTS TO DISTRACT AND FIXATE THE DEVICE, EFFECTIVE STABILITY COULD NOT BE ACHIEVED AFTER MULTIPLE TRIALS. THE IMPLANT CONTINUED TO EXHIBIT MIGRATION (MOVEMENT) WITHIN THE SITE. CONSEQUENTLY, THE UNSTABLE IMPLANT WAS REMOVED, AND A NEW IMPLANT OF THE SAME SIZE WAS INSERTED. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY WITHOUT FURTHER COMPLICATIONS. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24120815 ↗
• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE PLATE WOULD NOT TURN. ADDITIONALLY, MULTIPLE INSTANCES OF THE CENTERPIECES WERE NOTED TO HAVE LOCK SET SCREWS THAT SEEMED TO BE CROSS-THREADED. 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 22058253 ↗
• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE PLATE WOULD NOT TURN. ADDITIONALLY, MULTIPLE INSTANCES OF THE CENTERPIECES WERE NOTED TO HAVE LOCK SET SCREWS THAT SEEMED TO BE CROSS-THREADED. 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 22058252 ↗
• MalfunctionApr 24, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR CORPECTOMY SPI NAL THERAPY. IT WAS REPORTED THAT THE LOCKING SCREW DOES NOT TIGHTEN. 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 21896995 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING AN UNKNOWN SPINAL PROCEDURE. IT WAS REPORTED THAT THE IMPLANT WAS RELOADED ON THE INSERTER SEVERAL TIMES TO MAKE SURE IT WAS LOADED PROPERLY AND THE RING AND/OR SCREWDRIVER WERE USED TO TRY TO PROVISIONALLY LOCK EXPANSION WITH THE LOCKING SCREW. DIFFERENT IMPLANT WAS USED TO FINISH THE PROCEDURE. AFTER THE CASE, IMPLANT WAS INSPECTED AND TRIED TO ENGAGE THE LOCKING MECHANISM. EVEN PAST THE TORQUE LIMITING FEATURE ON THE SCREWDRIVER AND IT STILL COLLAPSED. 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 21583675 ↗
• MalfunctionMar 12, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT WHEN THE IMPLANT WOULD NOT FINAL TIGHTEN, THE CAGE WAS REMOVED FROM THE PATIENT AND ATTEMPTED TO ENGAGE THE LOCKING SCREW USING INSERTER OUTSIDE OF THE PATIENT. THE CAGE EXPANSION LOCKING SCREW WOULD NOT THREAD PROPERLY, LEADING TO INABILITY TO FINAL TIGHTEN CAGE AT CORRECT EXPANSION. THE INSERTER FINAL TIGHTENING DRIVER WOULD NOT ENGAGE PROPERLY WITH LOCKING SCREW ON CAGES, UNABLE TO FINAL TIGHTEN WITH INSERTER. THE SCREW DRIVER PARTIALLY STRIPPED AND UNABLE TO GET GOOD ENGAGEMENT WITH FINAL TIGHTENING DRIVER ON INSERTER. THE TORQUE HANDLE MAY HAVE CONTRIBUTED TO THE IMPLANT HAVING DIFFICULTLY LOCKING EXPANSION. 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 21581793 ↗