T2 STRATOSPHERE Expandable Corpectomy System 436113CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169634817), received between Jun 10, 2020 and Aug 16, 2023 — classified as 5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING AN EVENT WHICH OCCURRED DURING A PVCR PROCEDURE IN A PATIENT DIAGNOSED WITH L4 RUPTURE FRACTURE. IT WAS REPORTED THAT AFTER T3 WAS INSERTED INTO THE BODY, THE ADJUSTING END CAP WAS BORROWED AND FIXATED. BECAUSE IT WAS TILTED USING WIPER MOTION, IT WAS REMOVED FROM THE BODY AND WHEN THE SET SCREW WAS LOOSENED, THE ADJUSTING END CAP DISINTEGRATED. 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 17554265 ↗
• MalfunctionApr 19, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO UNDERWENT UNKNOWN SPINAL THERAPY FOR PSEUDOARTHROSIS OF VERTEBRAL FRACTURE. IT WAS REPORTED THAT THE END CAP DID NOT FIT ONTO CAGE, SO THE END CAP WAS HIT WITH A HAMMER. NO FURTHER COMPLICATIONS OR SYMPTOMS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT THE CENTERPIECE AND THE END CAP WERE NOT ENGAGED. THE REPORTED PRODUCTS WERE NOT BROKEN AND BOTH CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141329 ↗
• MalfunctionFeb 9, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY DUE TO CERVICAL TRAUMA. IT WAS REPORTED THAT ONCE THE CAGE HAS BEEN MOUNTED ON THE IMPLANT HOLDER, ITS EXPANSION WAS TESTED WITH THE SPECIAL BUTTERFLY HANDLE WITHOUT ENCOUNTERING ANY PROBLEMS. SUBSEQUENTLY, INSIDE THE PATIENT, THE SYSTEM SEEMED, HOWEVER, TO SPIN IN CIRCLES, CAUSING THE CAGE NOT MAINTAINING THE EXPANSION (AS IT COLLAPSED AFTER EACH TURN). SO CAGE WAS  IMMEDIATELY REPLACED WITH A NEW ONE. ONCE THE NEW PRODUCT WAS FITTED, THE SYSTEM WORKED PERFECTLY WITHOUT ANY PROBLEMS. 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 13495746 ↗
• MalfunctionJan 12, 2021Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING DEGENERATIVE CERVICAL STENOSIS FOR SPINAL THERAPY. IT WAS REPORTED THAT CAGE WAS CORRECTLY LOADED ON THE HOLDER BUT SURGEON WAS NOT ABLE TO EXPAND IT WHILE TURNING THE T-HANDLE. THE PRODUCT WAS IMPLANTED ON (B)(6) 2020 AND WAS EXPLANTED ON THE SAME DAY. THERE WAS 30 MINS OF PROCEDURAL DELAY. THERE WERE NO PATIENT SYMPTOMS/ COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153215 ↗
• MalfunctionJun 10, 2020Crack; Crack

  IT WAS REPORTED THAT INTRA-OP, WHILE DISTRACTING THE IMPLANT, A CRACK NOISE WAS HEARD AND DISTRACTION COULD NOT PROCEED. THE REPORTED IMPLANT WAS THEN EXCHANGED WITH THE ONE OF A LARGER SIZE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10139398 ↗