T2 STRATOSPHERE Expandable Corpectomy System 436113BRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169634800), received between Oct 6, 2021 and Feb 11, 2025 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING SPINAL PRODUCT THAT IS USED IN F RONT AND REAR COMBINED SURGERY DUE TO L3 VERTEBRAL BODY CRUSHING. LEVELS IMPLANTED WAS L2/3. IT WAS REPORTED THAT WHEN CAGE AND INSERTER WAS INSERTED INTO THE BODY AND EXPANDED, THE INSERTER DRIVER COULD NOT BE FULLY INSERTED AND WHEN TORQUE WAS APPLIED TO A CERTAIN EXTENT, THE INSERTER ROTATES IDLY AND IT COULD NOT BE EXPANDED FURTHER. THE END CAP WAS DETACHED AND FALLEN INTO THE BODY. THE CAGE WAS REMOVED AGAIN AND IT WAS CONFIRMED THAT EXPANSION COULD BE MADE EXTERNALLY. THERE WERE NO PROBLEMS. WHEN EXPANDED, THE INSERTER DRIVER SPINS IDLY WHEN TORQUE WAS APPLIED. THE LOCK ON THE INSERTER AND THE CAGE WAS NOT LOOSE AT THIS TIME. FOR THE TIME BEING, TEMPORARY FIXATION WAS ATTEMPTED USING A LOCKING RING OR TORQUE DRIVER IN ORDER TO TEMPORARILY FIXATE THE DEVICE, BUT NO MATTER HOW MANY TIMES IT WAS TURNED, THERE WAS NO HOLD OF IT AND IT CONTINUED TO ROTATE. HOWEVER, THE BONE BROKE WHILE THE DEVICE WAS REPEATEDLY INSERTED AND REMOVED. THERE WAS A DELAY OF LESS THAN 60 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIV

  Patient problems: Bone Fracture(s)

  MAUDE report 21353784 ↗
• MalfunctionOct 31, 2022Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR CERVICAL CORPE CTOMY. LEVEL IMPLANTED: C5 IT WAS REPORTED THAT THE IMPLANT, MOUNTED ON THE DEDICATED INSERTER, EXPANDED OUTSIDE THE PATIENT BUT ONCE IMPLANTED THE EXPANSION MECHANISM DIDN'T WORK. THE PRODUCT WAS IMPLANTED IN THE PATIENT FOR A FEW MINUTES. ONCE IMPLANTED, THE ITEMS PRESENTED AN EXPANDING ISSUE. SO THE IMPLANT WAS REPLACED WITH A NEW ONE OF THE SAME MEASURE. 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 15697777 ↗
• MalfunctionMar 7, 2022Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CORPECTOMY SPINAL THERAPY FOR C7 FRACTURE TRAUMA DUE TO AVALANCHE. IT WAS REPORTED THAT THE EXPANSION OF THE CAGE NOT POSSIBLE (RATCHET JUMP). THERE WAS NO PATIENT COMPLICATION AFTER SURGERY. THERE WAS 10MIN DELAY TO CHANGE THE IMPLANT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13680856 ↗
• MalfunctionDec 6, 2021Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT AFTER REMOVAL OF THE VERTEBRAL BODY IN THE CERVICAL SPINE, A STRATOSPHERE CAGE WAS IMPLANTED. THIS CAGE WAS NOT PLACED CORRECTLY AND DID NOT EVEN NEED TO BE REMOVED. WHEN THE CAGE WAS IMPLANTED AGAIN, IT COULD NO LONGER BE SPREAD OPEN. THE SAME WITH THE SECOND CAGE, BUT PROBABLY A SCREW BROKE. AFTER THE FAILED IMPLANTATION, A NEW CAGE WAS IMPLANTED. 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 12932207 ↗
• MalfunctionDec 6, 2021Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT AFTER REMOVAL OF THE VERTEBRAL BODY IN THE CERVICAL SPINE, A STRATOSPHERE CAGE WAS IMPLANTED. THIS CAGE WAS NOT PLACED CORRECTLY AND DID NOT EVEN NEED TO BE REMOVED. WHEN THE CAGE WAS IMPLANTED AGAIN, IT COULD NO LONGER BE SPREAD OPEN. THE SAME WITH THE SECOND CAGE, BUT PROBABLY A SCREW BROKE. AFTER THE FAILED IMPLANTATION, A NEW CAGE WAS IMPLANTED. 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 12932202 ↗
• MalfunctionOct 6, 2021Material Deformation; Mechanics Altered; Material Deformation; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CAFE IN AN ACDF/ CORPECTOMY AT C6 FOR AN UNKNOWN SPINAL INDICATION. IT WAS REPORTED THAT THE CAGE FAILED TO EXPAND AND LOCK A SECOND TIME. THE SURGEON WAS NOT SATISFIED WITH FIRST IMPLANTATION, REMOVED THE CAGE AND THEN RE-IMPLANTED. AT THIS TIME, THE CAGE FAILED TO PROPERLY ATTACH TO INSERTER. INTERNAL EXPANDER GEARING APPEARED STRIPPED. ANOTHER STRATOSPHERE CAGE (NEXT SIZE UP) WAS SUCCESSFULLY IMPLANTED WITHOUT ISSUE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THE EVENT. THE PROCEDURE DELAYED APPROX. 10-15 MINUTES DUE TO DIFFICULTIES WITH CAGE. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12581621 ↗