T2 STRATOSPHERE Expandable Corpectomy System 436120450Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169638426), received between Dec 25, 2019 and Jul 15, 2020 — classified as 6 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3 VERTEBRAL BODY REPLACEMENT SURGERY DUE TO VERTEBRAL FRACTURE. THE PATIENT WAS SCHEDULED TO HAVE AN OPERATION THAT SET T3 AT L3 AND PERFORM OLIF AT L4/5 ON (B)(6) AND PERFORM PLIF AT L5/S AND POSTERIOR FIXATION ON (B)(6). DURING HOSPITALIZATION AFTER (B)(6) 2020 OPERATION, THE PATIENT WORE A CORSET AND WALKED TO A SEATED MEAL AND THE TOILET. POSTOPERATIVE PHOTOGRAPH WAS TAKEN ON (B)(6) 2020 AND IT SEEMED THAT THE IMPLANTED END CAP WAS ALREADY TILTED COMPARED TO THE STATE DURING SURGERY. ON (B)(6) WHILE TAKING RADIOGRAPHIC IMAGE DURING THE PREOPERATIVE DIAGNOSIS, IT WAS FOUND THAT THE IMPLANTED CAGE HAD BACKED OUT/MIGRATED. THE ANGLE OF THE END CAP HAD CHANGED. IN THE OPERATION PERFORMED ON (B)(6) 2020, IT WAS PLANNED TO PERFORM PLIF AT L5/S AND POSTERIOR FIXATION, BUT IT WAS NECESSARY TO REPLACE THE T3 CAGE, SO THE CAGE WAS REPLACED. IT WAS POSSIBLE THAT THE CONTRALATERAL DISC CURETTAGE WAS NOT PERFORMED PERFECTLY, BUT AS PER THE SURGEON OPINION, THE VERTEBRAL BODY WAS RAISED WELL DURING THE INTRA-OPERATIVE LENGTHENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10274627 ↗
• InjuryJul 15, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT UNDERWENT L3 VERTEBRAL BODY REPLACEMENT SURGERY DUE TO VERTEBRAL FRACTURE. THE PATIENT WAS SCHEDULED TO HAVE AN OPERATION THAT SET T3 AT L3 AND PERFORM OLIF AT L4/5 ON (B)(6) AND PERFORM PLIF AT L5/S AND POSTERIOR FIXATION ON (B)(6). DURING HOSPITALIZATION AFTER (B)(6) 2020 OPERATION, THE PATIENT WORE A CORSET AND WALKED TO A SEATED MEAL AND THE TOILET. POSTOPERATIVE PHOTOGRAPH WAS TAKEN ON (B)(6) 2020 AND IT SEEMED THAT THE IMPLANTED END CAP WAS ALREADY TILTED COMPARED TO THE STATE DURING SURGERY. ON (B)(6), WHILE TAKING RADIOGRAPHIC IMAGE DURING THE PREOPERATIVE DIAGNOSIS, IT WAS FOUND THAT THE IMPLANTED CAGE HAD BACKED OUT/MIGRATED. THE ANGLE OF THE END CAP HAD CHANGED. IN THE OPERATION PERFORMED ON (B)(6) 2020, IT WAS PLANNED TO PERFORM PLIF AT L5/S AND POSTERIOR FIXATION, BUT IT WAS NECESSARY TO REPLACE THE T3 CAGE, SO THE CAGE WAS REPLACED. IT WAS POSSIBLE THAT THE CONTRALATERAL DISC CURETTAGE WAS NOT PERFORMED PERFECTLY, BUT AS PER THE SURGEON OPINION, THE VERTEBRAL BODY WAS RAISED WELL DURING THE INTRA-OPERATIVE LENGTHENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10274621 ↗
• InjuryJun 16, 2020Migration; Migration

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH L4 OSTEOPOROTIC VERTEBRAL FRACTURE; AND UNDERWENT ANTERIOR REPLACEMENT OF L4 VERTEBRAL BODY AND ANTERIOR LUMBAR FIXATION. THE ANGLE OF THE END CAP 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 10160810 ↗
• InjuryMar 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT VERTEBRAL BODY ANTERIOR REPLACEMENT AT L2 DUE TO COMPRESSION FRACTURE OF VERTEBRAL BODY. POST-OP, IT WAS FOUND THAT THE CAGE HAS BACKED OUT BY CHECKING X-RAY IMAGE AFTER 2 WEEKS OF OPERATION. THE PATIENT WAS ABLE TO WALK WITH A CANE AND THERE WAS NO HEALTH DAMAGE IN THE PATIENT AT THIS POINT. HOWEVER, IT WAS CHECKED BY IMAGE THAT THE EXTENDED ENDCAP HAS CONTACTED WITH THE KIDNEY AND IT WAS FORECASTED THAT SERIOUS DAMAGE WILL OCCUR IF THE CAGE CONTACTS WITH THE ANTERIOR MAJOR BLOOD VESSEL. BONE QUALITY WAS VERY BAD. IT WAS FOUND BY CHECKING THE X-RAY IMAGE TAKEN IN THE FIRST WEEK AFTER THE OPERATION THAT THE VERTEBRAL BODY OF THE MOST UPPER LEVEL FRACTURED. MAYBE THE SCREW AT L4 LOOSENED. HENCE AN REVISION SURGERY PERFORMED ON (B)(6) 2020 IN WHICH ALL OF THE SCREWS ON THE POSTERIOR SIDE WERE REMOVED AND TO REPLACE THE SCREWS WITH THICK SCREWS AND AFTER THAT, RETRIEVE THE CAGE WHICH BACKED OUT TO THE ANTERIOR SIDE AND TO INSERT AUTOLOGOUS BONE.

  Patient problems: Bone Fracture(s)

  MAUDE report 9881765 ↗
• InjuryDec 25, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ADJUSTABLE END CAP HAD NOT BEEN LOCKED AFTER FINAL TIGHTENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517755 ↗
• InjuryDec 25, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  THE ADJUSTABLE END CAP HAD NOT BEEN LOCKED AFTER FINAL TIGHTENING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9517752 ↗