T2 STRATOSPHERE Expandable Corpectomy System 436120400Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169638419), received between Jan 15, 2020 and Jul 1, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 1, 2020Migration; Migration

  PRE OP DIAGNOSIS: VERTEBRAL BODY BURST FRACTURE PROCEDURE PERFORMED: L2 REPLACEMENT OF VERTEBRAL BODY, T12-L4 POSTERIOR PPS LEVELS IMPLANTED: L2 POSTERIOR T12-L4 IMPLANT DATE: (B)(6) 2020 EXPLANT DATE: (B)(6) 2020(PLANNED) DEVICE STATUS: EXPLANT PLANNED IT WAS REPORTED THAT POST OP, CAGE BACKED OUT. THE CAGE, WHICH WAS INSERTED ABOUT 2 WEEKS, BACKED OUT AFTER THE OPERATION. THE EXTENT OF BACKING OUT WAS UNKNOWN. IT WAS PLANNED TO PERFORM A REOPERATION ON (B)(6) 2020 (PLAN TO REMOVE THE CAGE THAT HAS BACKED OUT AND REPLACE IT WITH T2). THE POSTERIOR SIDE HAS BEEN FIXED WITH V4, AND THE ANTERIOR VERTEBRAL BODY REPLACEMENT WAS PERFORMED AFTER THE POSTERIOR FIXATION. THE CAGE ON THE CRANIAL SIDE WAS PLACED IN THE DIRECTION OF THE ADJUSTING END CAP. PATIENT COMPLICATIONS WERE UNKNOWN. THE CAGE BACKED OUT AFTER THE OPERATION, SO HOSPITALIZATION WAS PROLONGED FOR THE REVISION SURGERY. IN REVISION SURGERY PERFORMED T2 STRATOSPHERE WAS REMOVED AND WAS REPLACED WITH T2 ALTITUDE. THERE WAS PATIENT COMPLICATION OCCURRED WHICH NEED TO PERFORM A RE-OPERATION. IT SEEMED THAT THE CAGE HAD BEEN PLACED WITH THE UPPER LEVEL DISC REMAINING. END CAP ATTACHED TO THE HEAD AND TAIL SIDE, SELF-ADJUSTING EN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216990 ↗
• InjuryJan 15, 2020No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  LEVELS IMPLANTED: L3-5 IT WAS REPORTED THAT THE PATIENT UNDERWENT REPLACEMENT OF L4 VERTEBRAL BODY DUE TO PSEUDOARTHROSIS OCCURRED AFTER THE VERTEBRAL BODY FRACTURE AT L4. OSTEOTOMY ON THE CONTRALATERAL SIDE WAS NOT DONE ENOUGH DURING CAGE PLACEMENT, SO CAGE PLACEMENT WAS PERFORMED NEAR THE APPROACHING SIDE. ALTHOUGH THE SURGEON ALSO ACKNOWLEDGED THAT THE OSTEOTOMY WAS NOT DONE ENOUGH, THE OPERATION WAS COMPLETED AS IT WAS. POST-OP, THE END CAP WAS NOT AT THE CENTER, BUT JUST BARELY REACHED THE END OF THE VERTEBRAL BODY WHEN THE CAGE WAS PLACED. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT. DEVICE HAS BEEN REMOVED FROM THE PATIENT BODY IN THE REVISION SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9590303 ↗