T2 STRATOSPHERE™ Expandable Corpectomy System 4360258 (UDI 00643169650992)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169650992), received between Sep 16, 2022 and Nov 19, 2025 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2025Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING LUMBAR 2 VERTEB RAL BODY RESECTION & SCREW-ROD INTERNAL FIXATION & PROSTHESIS REPLACEMENT FOR AN INDICATION OF LUMBAR METASTATIC TUMOR. IT WAS REPORTED THAT THE END CAP WAS BROKEN DURING THE OPERATION. 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 23592009 ↗
• InjurySep 11, 2025Migration; Migration

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED POST A CORPECTOMY PROCEDURE IN A PATIENT DIAGNOSED WITH TUMOR. IT WAS REPORTED THAT THE PROSTHETIC VERTEBRAL BODY LOOSENED AND MIGRATED. THE CAGE AND ENDCAP WERE EXPLANTED. 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 23028784 ↗
• InjurySep 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTEROLATERAL C ORPECTOMY FOR BURST FRACTURE. LEVELS IMPLANTED: L4 IT WAS REPORTED THAT THAT DEVICES BROKE AND WERE EXPLANTED. NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. IMMEDIATELY POST OP, THE PATIENT WAS NEUROLOGICALLY INTACT. HOWEVER, AFTER UNDERGOING PHYSICAL THERAPY, THE PATIENT DEVELOPED SOME NEUROLOGICAL DEFICIT IN THE LEFT LOWER EXTREMITY. THE PATIENT WAS BROUGHT BACK IN FOR IMAGING AND THE INSTRUMENTATION WAS INTACT. IT WAS THE SURGEONS BELIEF THAT THE PATIENT HAS DEVELOPED A PALSY DUE TO THE EXTENDED RETRACTION ON THE PSOAS MUSCLE. ONE OF THE CONTRIBUTING FACTORS IN THE AMOUNT OF TIME THE PSOAS WAS UNDER RETRACTION WAS DUE TO THE ISSUES WITH THE EXPANDABLE CORPECTOMY DEVICE. THESE ISSUES INCREASED THE AMOUNT OF TIME IT TOOK TO COMPLETE THE CORPECTOMY BY ABOUT AN HOUR. ALL THREE DEVICES CONTRIBUTED TO THE DELAY: THE EXTRA TIME TO REMOVE AND THEN ATTEMPT TO RESNAP THEM BACK ON, ETC. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 15436865 ↗
• InjurySep 16, 2022Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING ANTEROLATERAL C ORPECTOMY FOR BURST FRACTURE. LEVELS IMPLANTED: L4 IT WAS REPORTED THAT THAT DEVICES BROKE AND WERE EXPLANTED. NO FRAGMENTS WERE LEFT IN THE PATIENT. THERE WAS NO PATIENT SYMPTOM REPORTED. IMMEDIATELY POST OP, THE PATIENT WAS NEUROLOGICALLY INTACT. HOWEVER, AFTER UNDERGOING PHYSICAL THERAPY, THE PATIENT DEVELOPED SOME NEUROLOGICAL DEFICIT IN THE LEFT LOWER EXTREMITY. THE PATIENT WAS BROUGHT BACK IN FOR IMAGING AND THE INSTRUMENTATION WAS INTACT. IT WAS THE SURGEONS BELIEF THAT THE PATIENT HAS DEVELOPED A PALSY DUE TO THE EXTENDED RETRACTION ON THE PSOAS MUSCLE. ONE OF THE CONTRIBUTING FACTORS IN THE AMOUNT OF TIME THE PSOAS WAS UNDER RETRACTION WAS DUE TO THE ISSUES WITH THE EXPANDABLE CORPECTOMY DEVICE. THESE ISSUES INCREASED THE AMOUNT OF TIME IT TOOK TO COMPLETE THE CORPECTOMY BY ABOUT AN HOUR. ALL THREE DEVICES CONTRIBUTED TO THE DELAY: THE EXTRA TIME TO REMOVE AND THEN ATTEMPT TO RESNAP THEM BACK ON, ETC. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Peripheral Nervous Injury

  MAUDE report 15436851 ↗