T2 STRATOSPHERE™ Expandable Corpectomy System 436013B (UDI 00763000856250)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00763000856250), received between Nov 14, 2024 and Mar 14, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionSep 11, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT HAVING C6 CORPECTOMY. IT WAS REPORTED THAT SURGEON TRIED TO FINAL TIGHTEN AND THE SET SCREW WOULD NOT TORQUE OUT, DESPITE TRYING TWO DIFFERENT HANDLES. 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 23027949 ↗
• MalfunctionMay 29, 2025Crack; Crack

  INFORMATION WAS RECEIVED FROM THE USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE DEVICE CRACKED. 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 22102912 ↗
• 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 22058207 ↗
• MalfunctionMar 19, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A CENTERPIECE CAGE USED IN AN CORPECTOMY SURGERY. IT WAS REPORTED THAT THE LOCKING SCREW IN THE IMPLANT WAS EXTREMELY DIFFICULT TO HAND LOOSEN AND TIGHTEN, MAKING IT DIFFICULT TO USE WITH THE HELP OF AN INSERTER. THIS WAS A ROUTINE CHECK OF IMPLANTS AND NOTICED DURING NORMAL SET ORGANIZATION. 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 21641012 ↗
• MalfunctionMar 19, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MEDTRONIC REPRESENTATIVE REGARDING A CENTERPIECE USED IN A UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT SCREW IN THE IMPLANT DAMAGED AND IT WAS DISCARDED BY SPD. ITEM WAS FOUND TO BE DYSFUNCTIONAL DURING PROCESSING BY SPD. THERE WAS NO PATIENT INVOLVED IN THIS EVENT. THIS PRODUCT WAS IDENTIFIED AS MALFUNCTIONED STRAIGHT FROM THE BOX AND IT HAS NOT BEEN USED IN ANY OTHER PRIOR PROCEDURE/ SURGERY. THERE WERE NO FURTHER COMPLICATIONS THAT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640439 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE LOCKING SCREW WAS TOO TIGHT. COULD NOT GET IT TO TURN IT LOOSE ENOUGH. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS OUT OF BOX FAILURE ITEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602745 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE PLANNED TO USE FOR A SPINAL THERAPY. IT WAS REPORTED THAT, THE LOCKING SCREW DOESN'T WORK, THE CAGE WAS DELIVERED DEFECTIVE. THE PROCEDURE OR TECHNIQUE PLANNED WAS ANTERIOR CERVICAL INTERBODY FUSION. THERE WAS NO PATIENT INVOLVEMENT REPORTED. NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21602721 ↗
• MalfunctionMar 14, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED IN A SPINAL THER APY. IT WAS REPORTED THAT THE LOCKING SCREW WAS TOO TIGHT EVEN AFTER LUBRICATING IT AND IT COULD NOT BE TURNED. 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 21602701 ↗
• 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 21581780 ↗
• MalfunctionMar 10, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, USER FACILITY) REGARDING A DEVICE USED FOR SPINAL THERA PY. IT WAS REPORTED THAT WHILE ASSEMBLING THE TRAY, IT WAS NOTICED THE CAGE WAS NOT EXPANDING PROPERLY. IT WAS NOT OPENING AND CLOSING SMOOTHLY LIKE IT IS SUPPOSED TOO. 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 21558046 ↗
• MalfunctionFeb 13, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING PLF T12-L4/CORP ECTOMY SPINAL THERAPY FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT ONCE THE B CAGE WAS LOADED ONTO THE INSERTER, ATTEMPT WAS MADE TO PROVISIONALLY LOCK THE CAGE IN EXPANSION AND FOUND THAT THE SET SCREW WOULD NOT TURN. 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 21372279 ↗
• MalfunctionFeb 4, 2025Break; Break

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, DISTRIBUTOR) REGARDING A DEVICE USED FOR CORPECTOMY. IT WAS REPORTED THAT THE DEVICE BROKE. 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 21303549 ↗
• MalfunctionNov 14, 2024Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT UNDERGOING ANTERIOR CE RVICAL CORPECTOMY SPINAL THERAPY. LEVELS IMPLANTED AT C5. IT WAS REPORTED THAT WHEN TRYING TO LOCK THE IMPLANT WHEN IT WAS EXPANDED, THE LOCKING MECHANISM WAS ABNORMALLY DIFFICULT TO TURN AN D CENTERPIECE WOULDN'T LOCK. THERE WAS NO PATIENT SYMPTOM REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE DEVICE WAS NEW AND NOT USED BEFORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20681377 ↗