T2 STRATOSPHERE Expandable Corpectomy System 436120BRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169634855), received between Dec 29, 2019 and Jan 5, 2022 — classified as 2 injuries, 2 malfunctions.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 5, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN THE REPORTED EVENT. LEVELS IMPLANTED: T10-L5. IT WAS REPORTED THAT THEY PERFORMED VERTEBRAL BODY REPLACEMENT AND POSTERIOR FUSION OF T11.12.L2 FOR L1 BURST. AFTER THAT, THE T3 VERTEBRAL BODY REPLACEMENT CAGE SUNK TO THE L2 VERTEBRAL BODY, AND AT THE SAME TIME, THE L2 SCREW BACKED OUT. THE L2 SCREW WAS REMOVED AND SINCE THERE WAS BKP IN L3, SCREW WAS ADDED TO L4.5 AND T10 TO EXTEND AND RE-FIXED. THERE WAS NO MALFUNCTION WITH THE PRODUCTS. PATIENT SYMPTOMS- DORSAL PAIN WAS REPORTED. PATIENT WAS HOSPITALIZED PROLONG AS A RESULT OF THIS EVENT.

  Patient problems: Pain

  MAUDE report 13168723 ↗
• InjuryJul 1, 2020Migration; Migration

  PATIENT DEMOGRAPHICS: GENDER- FEMALE 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. UPDATE RECEIVED ON THR

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10216971 ↗
• InjuryMay 7, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4 OSTEOPOROTIC VERTEBRAL FRACTURE; AND UNDERWENT ANTERIOR REPLACEMENT OF L4 VERTEBRAL BODY. THE ANGLE OF THE IMPLANT WAS FIXED AT AN APPROPRIATE ANGLE. ON AN UNKNOWN DATE, POST-OP, THE ANGLE OF THE ADJUSTABLE END CAP APPEARED TO HAVE CHANGED. THE IMPLANT WAS CONSIDERED TO HAVE MIGRATED. HENCE, A REVISION SURGERY WAS PERFORMED, IN WHICH THE IMPLANT WAS REMOVED AND WAS REPLACED WITH A NEW ONE (MANUFACTURED BY ANOTHER COMPANY). THE SURGEON REPORTED THAT THE PATIENT IS RECOVERING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10033027 ↗
• MalfunctionDec 29, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PSEUDOARTHROSIS AFTER OSTEOPOROTIC VERTEBRAL FRACTURE AT T12. SHE UNDERWENT SUBTOTAL REMOVAL AT T12; AND ANTERIOR FIXATION AT T11-L1. INTRA-OP, WHEN ATTEMPTING TO PERFORM FINAL TIGHTENING FOR THE SET SCREW ON THE CRANIAL SIDE, THE SET SCREW COULD NOT BE CONFIRMED UNDER DIRECT VISION. THEN, THE SALES REP HAD A CONVERSATION WITH THE SURGEON, AND IT WAS DECIDED TO REMOVE THE INSERTER FIRST AND THEN TO PERFORM FINAL TIGHTENING FOR THE SET SCREW ON THE CRANIAL SIDE. SO, WHEN TRYING TO REMOVE THE INSERTER FROM THE CAGE, THE CAGE WAS ALSO REMOVED OUT OF THE OPERATION FIELD. WHEN TRYING TO LOOSEN THE SET SCREW IN THE CENTER, IT DID NOT COME LOOSE. HENCE, A REMOVAL TOOL WAS USED, AND THE EXTEND CAP WAS REMOVED. AT THAT TIME, THE CAGE BROKE INTO TWO PARTS WITH A CRISP SOUND. THE BROKEN CAGE WAS COMPLETELY OUT OF THE PATIENT WITH NO FRAGMENTS OF THE CAGE REMAINING INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW CAGE. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME AS A RESULT OF THIS EVENT BUT NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9528632 ↗