T2 STRATOSPHERE™ Expandable Corpectomy System 436013D (UDI 00643169663145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169663145), received between May 25, 2021 and Jul 25, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT DURING THE PLACEMENT OF THE CAGE, THE SCREW DRIVER SPUN FREELY AND WOULD NOT TIGHTEN WHEN THE SURGEON ATTEMPTED TO LOCK THE IMPLANT HEIGHT, DESPITE SEVERAL ATTEMPTS. THE ORIGINAL IMPLANT WAS REPLACED WITH A NEW IMPLANT TO COMPLETE THE SURGERY. THE ORIGINAL PRODUCT WAS EXPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PROCEDURE INVOLVED DURING THE EVENT WAS A TUMOR SURGERY, DURING WHICH THE CORPECTOMY TECHNIQUE WAS APPLIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607590 ↗
• MalfunctionMar 7, 2022Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT LOCK SCREW OF CAGE BECAME CROSS THREADED DURING LOOSENING AND WOULD TORQUE OUT BEFORE BEING LOCKED INTO POSITION. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. 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 13681979 ↗
• MalfunctionDec 21, 2021Break; Break

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CERVICAL CORPECTOMY SPINAL THERAPY AT C4. IT WAS REPORTED THAT TOOTH ON WORM GEAR INSIDE OF CENTERPIECE BROKE OFF DURING EXPANSION. PREVENTED SURGEON FROM USING THE CAGE TO DISTRACT UNDER LOAD. THE PART CAME IN CONTACT WITH THE PATIENT. 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 13050182 ↗
• MalfunctionJun 8, 2021Mechanical Jam; Mechanical Jam

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH UNKNOWN INDICATION INVOLVED IN C5-C6 CORPECTOMY WITH T2 STRATOSPHERE. IT WAS REPORTED THAT DURING PROCEDURE, TRIED TO REMOVE THE INSERTER, CAGE WOULD NOT DISENGAGE. TRIED TRANSLATING IT CEPHALAD, ROCKING IT MEDIAL-LATERAL, CEPHALAD-CAUDAL, AND 360 DEGREES. WHEN THEY PULLED THE INSERTER BACK THE CAGE CAME OUT WITH IT DUE TO THE CEPHALAD LOCKING MECHANISM NOT RELEASING FROM THE CAGE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. PATIENT IS ALIVE AND NO INJURY. ON 2021-JUNE-07, RECEIVED ADDITIONAL INFORMATION THAT, WHEN THEY EXPANDED THE CAGE, LOCKED IT INTO PLACE, TRIED TO RELEASE THE CAGE FROM THE INSERTER AND THEY COULD NOT GET THE INSERTER TO RELEASE FROM THE IMPLANT. THERE WAS A DELAY IN PROCEDURE TIME, ESTIMATED THAT IT ADDED 50 MINUTES TO THE CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963286 ↗
• MalfunctionMay 25, 2021Break; Activation Failure; Break; Activation Failure

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A SPINAL PRODUCT TYPE FOR UNKNOWN INDICATION. IT WAS REPORTED THAT INTRA-OP, TEETH ON RACK/PINION PART OF IMPLANT SHEARED OFF. THIS RESULTED IN THE IMPLANT NOT EXPANDING PROPERLY AND IT WAS EXPLANTED. THE IMPLANT WAS REMOVED AND INSPECTED, AND IT WAS FOUND THAT THE EXPANSION MECHANISM WOULD NOT WORK BECAUSE IT HAD SHEARED OFF DURING THE ATTEMPT TO EXPAND. THERE WAS A DELAY OF ROUGHLY 10 MINS IN OVERALL PROCEDURE TIME. THERE WERE NO FRAGMENTS LEFT INSIDE THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11875057 ↗