T2 STRATOSPHERE™ Expandable Corpectomy System 436013D (UDI 00763000856274)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000856274), received between May 12, 2025 and Aug 4, 2025 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 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 22703085 ↗
• MalfunctionJun 3, 2025Mechanical Problem; Material Deformation; Mechanical Jam; Mechanical Problem; Material Deformation; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING POSTERIOR T12 CORPECTOMY. IT WAS REPORTED THAT THE DEVICE STUCK IN MID EXPANSION, WAS NOT EXPANDING AND COLLAPSING AS IT SHOULD AND STRIPPING WHILE ATTEMPTS WERE MADE TO EXPAND AND COLLAPSE THE CAGE. 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 22129561 ↗
• MalfunctionMay 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 DURING A SPINAL PROCEDURE INVOLVING THE TECHNICAL TEAM ENCOUNTERED SEVERAL ISSUES. INITIALLY, AFTER BREAKING OFF THE VERIFY TAB AND LOADING THE DEVICE ONTO THE INSERTER, THE DEVICE COULD NOT BE COLLAPSED. MULTIPLE ATTEMPTS WERE MADE TO RECONNECT THE INSERTER, AND EVENTUALLY, THE LOCK SCREWDRIVER WAS USED TO LOOSEN THE LOCKING MECHANISM, ALLOWING THE DEVICE TO COLLAPSE AND EXPAND. DURING THE EXPANSION, A CRUNCHING SOUND WAS HEARD, AND UPON ATTEMPTING FINAL TIGHTENING, A GRINDING SOUND WAS NOTED. THE DEVICE FAILED TO MAINTAIN ITS EXPANSION AND WAS SUBSEQUENTLY REMOVED. THERE WERE NO PATIENT COMPLICATIONS OR SYMPTOMS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT PATIENT HAD A PRIOR EMERGENCY SURGERY AT ANOTHER FACILITY DUE TO LOSING MOTOR AND SENSORY FUNCTIONS. AN EMERGENCY LAMINECTOMY WAS DONE TO ALLEVIATE THE PRESSURE ON THE SPINAL CORD AND TRY TO RESTORE FUNCTIONS. THE PATIENT EVENTUALLY NOW CAME WITH A KYPHOSIS OF THE CERVICAL SPINE AND INFECTION. A TWO LEVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22000466 ↗