T2 STRATOSPHERE Expandable Corpectomy System 436113DRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169634824), received between Feb 14, 2022 and Dec 7, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Mechanics Altered” (2 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.

• MalfunctionDec 7, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH SPINAL THERAPY. IT WAS REPORTED THAT COULDN'T LOCK CAGE BECAUSE SET SCREW WAS BINDED UP. STERILE PACKED IMPLANT. SURGERY DELAYED BY 45 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18280486 ↗
• MalfunctionJul 29, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MEDTRONIC REPRESENTATIVE REGARDING A CAGE AND END CAP TO BE IMPLANTED IN A PATIENT DURING A VERTEBRAL BODY REPLACEMENT FOR AN L1 VERTEBRAL BODY COMPRESSION. IT WAS REPORTED THAT F13D 16 MM CAP WAS INSERTED IN L1 AND INSTALLED IN THE VERTEBRAL BODY. IT WAS ABLE TO BE INSTALLED, EXPANDED, AND THE FINAL TIGHTENING WAS PERFORMED. T2 ITSELF ALSO MOVED A LITTLE WHEN REMOVING THE CAGE FROM THE HOLDER, SO IT WAS REMOVED. THE REMOVED CAGE WAS PERFORMING A FINAL, BUT IT WAS EXPANDED WHEN THE PHYSICIAN HELD IT. SINCE IT WAS EXPANDED DESPITE BEING FINAL, IT WAS NOT REINSTALLED AND WAS REPLACED WITH F20 CAGE. THE CENTERPIECE COULD NOT BE FASTENED IN THE PATIENT'S BODY. THE END CAP WAS TOO HARD TO BE ATTACHED. THE PRODUCTS WERE USED ON THE PATIENT AND THE PATIENT WAS ON THE OPERATING TABLE WHEN THE PRODUCTS MALFUNCTIONED. THERE WERE NO SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. IT WAS UNKNOWN IF THE PATIENT NEEDED TO BE HOSPITALIZED/ STAY LONGER. THE DATES OF IMPLANT AND EXPLANT WAS (B)(6) 2022. NO FURTHER COMPLICATIONS WERE REPORTED/ ANTICIPATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15127510 ↗
• InjuryFeb 14, 2022Activation Problem; Activation Problem

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH A CENTERPIECE AND ANTERIOR PLATE ZEVO IN A SOMATECTOMY. IT WAS REPORTED THAT DURING THE FIRST SURGERY ON (B)(6) 2022, THE CAGE DIDN'T MAINTAIN THE EXPANSION, SO IT WAS REPLACED WITH ANOTHER CAGE USING THE TWO ENDPLATES TO GIVE LORDOSIS. THE ENDPLATE HAD DIFFICULTIES TO ASSEMBLE THE CENTRAL PIECE DURING THE SAME SURGERY. 1 DAY POST-OP, THE PATIENT REPORTED THE SENSATION OF ¿CRUNCHING¿ AT THE CERVICAL LEVEL. FOLLOWING DIAGNOSTIC IMAGING, IT WAS FOUND THAT THE CRANIAL ENDPLATE HAD LOST THE LORDOSIS DETERMINED DURING THE SURGERY. THE DYNAMOMETRIC CLOSURE OF THE NUT INHERENT IN THE DEFINITIVE POSITIONING OF THE CRANIAL ENDPLATE TOOK PLACE WITHOUT ANY PROBLEM. NO REVISION WAS MADE. ON THE (B)(6) 2022, IT WAS REPORTED THAT FOLLOWING A DOMESTIC QUARREL WITHOUT A COLLAR, THE PATIENT UNDERWENT TWO FRONTAL FALLS WITH RELATIVE LOSS OF CONSCIOUSNESS. AFTER RECOVERING FROM THE SECOND FALL, TETRAPLEGIA WAS FOUND. UPON ARRIVAL IN THE FACILITY, THE DIAGNOSTIC IMAGES REVEALED IMPLANT MOBILIZATION. ON (B)(6) 2022, A REVISION SURGERY WAS MADE TO REMOVE THE MEDICAL DEVICES. WHI

  Patient problems: Loss of consciousness

  MAUDE report 13521310 ↗