T2 STRATOSPHERE™ Expandable Corpectomy System 436020D (UDI 00643169663190)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169663190), received between Sep 17, 2018 and Jun 12, 2024 — classified as 1 death, 1 injury, 4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathJun 12, 2024Difficult to Remove; Difficult to Remove

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH CENTERP IECE HAVING POSTERIOR LUMBAR SPINE TUMOR EN-BLOCK RESECTION (EN-BLOCK SURGERY)THERAPY FOR SPINAL TUMOR. IT WAS REPORTED THAT THE ARTIFICIAL VERTEBRA CAUSED PATIENT DEATH. THE PRODUCT PROLONGED THE OPERATION TIME, THE OPERATION WAS EXPECTED TO BE COMPLETED IN 4 HOURS, DUE TO THE ARTIFICIAL VERTEBRAL BODY PLACEMENT, THE OPERATION TIME WAS INCREASED BY 3 HOURS. SO THE PRODUCT PROLONGED THE OPERATION TIME, CAUSED EXCESSIVE BLOOD LOSS, AND RESULTED IN THE PATIENT'S DEATH AFTER SURGERY. PRODUCT PROLONGED OPERATION TIME BECAUSE IT WAS DIFFICULT TO REMOVE T2 ARTIFICIAL VERTEBRAL BODY HOLDER AFTER IMPLANTATION. DIFFICULTY IN REMOVAL MEANT THAT THE RETAINER AND THE PROSTHETIC IMPLANT COULD NOT BE SEPARATED AND THE RETAINER COULD NOT BE REMOVED. IT WAS UNKNOWN WHETHER ANY DEVICE ISSUE HAS LED TO PATIENT'S DEATH. THE PATIENT UNDERWENT SURGERY ON (B)(6) 2023 AND DIED ON (B)(6) 2024. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19517903 ↗
• MalfunctionDec 15, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY FOR UNKNOWN INDICATION. IT WAS REPORTED THAT CAGE COULD NOT BE OPENED DURING SURGERY.  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 18336332 ↗
• MalfunctionJul 31, 2023Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING CORPECTOMIES FOR INFECTION AT T8 AND T9. IT WAS REPORTED THAT WHEN IMPLANTING AND EXPANDING THE DEVICE, THE CENTERPIECE LOCKING SCREW DID NOT ENGAGE AND WOULD NOT LOCK THE IMPLANT INTO A FIXED POSITION. THE SURGEON IMPLANTED AND EXPANDED THE DEVICE USING THE TECHNIQUE INSTRUCTIONS, LOCKED THE IMPLANT TO THE TORQUE LIMITING SPECIFICATIONS, BUT THE DEVICE COLLAPSED WHEN THE EXPANSION SCREWDRIVER WAS REMOVED. MULTIPLE DIFFERENT WAYS OF TROUBLESHOOTING WAS TRIED BY USING THE LOCKING RING ON THE INSERTER HANDLE AS WELL AS TRYING TO TIGHTEN AND LOOSEN THE LOCKING MECHANISM WITH THE SYSTEM SCREWDRIVER. BUT NOTHING MADE A DIFFERENCE. EVENTUALLY THE IMPLANTED DEVICE WAS REMOVED FROM THE PATIENT, REMOVED IT FROM THE INSERTER AND INSPECTED. THE CENTERPIECE LOCKING SCREW HAD GOTTEN BACKED OUT SO MUCH THAT IT WOULD NOT RE-ENGAGE THE DEVICE TO TIGHTEN UP. THE PRODUCT WAS EXPLANTED AND NEW IMPLANT WAS USED. 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 17422006 ↗
• InjuryMar 4, 2021Naturally Worn; Activation Failure; Naturally Worn; Activation Failure

  INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF TUMOR OF L5 WHICH REQUIRED L5 CORPECTOMY AND FUSION. IT WAS REPORTED THAT INTRA-OP, THE IMPLANT WAS PLACED IN THE L5 CAVITY WHERE THE CORPECTOMY WAS PERFORMED. THE CAGE WAS THEN EXPANDED IN-SITU. ONCE THE CAGE ENGAGED THE L4/ S1 END PLATES THE RATCHET MECHANISM STARTED SLIPPING AND THEREFORE THE CAGE WOULD NOT EXPAND ENOUGH. THE TEETH INSIDE THE CENTERPIECE BECAME WORN AND FLAT. THEREAFTER THE CAGE WOULD NOT EXPAND OR COLLAPSE WHEN TURNING THE HANDLE ON THE INSERTER. THE ADJUSTABLE ENDPLATE ON THE CENTERPIECE WAS ADJUSTED, TORQUED AND LOCKED TO A LORDOTIC ANGLE AND BEFORE CAGE INSERTION. THIS ANGLE WAS LOST EVERY TIME THE CAGE WAS EXPANDED IN-SITU. THIS HAPPENED TO BOTH REPORTED CENTERPIECES. ALTHOUGH THE ENDCAPS WERE ATTACHED TO THE CAGES, NO FAULT TO THE END CAPS NOTED. ONLY THE CENTERPIECES WERE FAULTY. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PROCEDURE RESULTED IN LONGER THEATRE AND ANESTHETIC TIME AND INCREASED BLOOD LOSS. THERE WAS DELAY OF 90 MINUTES IN OVERALL PROCEDURE TIME.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Oversedation

  MAUDE report 11410562 ↗
• MalfunctionSep 19, 2019Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT INTRA-OP, INITIAL THREADS OF THE IMPLANT STRIPPED AND SHEARED, WHICH DID NOT ALLOW CAGE TO EXPAND. THE IMPLANT WAS THEN COMPLETELY EXPLANTED; AND WAS REPLACED BY ANOTHER PRODUCT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9085388 ↗
• MalfunctionSep 17, 2018Peeled/Delaminated; Naturally Worn; Peeled/Delaminated; Naturally Worn

  PROCEDURE: CORPECTOMY PRE-OPERATIVE DIAGNOSIS: TRAUMA BURST FRACTURE IMPLANTED LEVEL: L3 IT WAS REPORTED THAT ON (B)(6) 2018, INTRA-OP, STRATOSPHERE CAGE STRIPPED. THE PRODUCT CAME IN CONTACT WITH THE PATIENT. IT APPEARED THAT SOME METAL MAY HAVE PEELED OFF. NO FRAGMENT OF THE IMPLANT OR INSTRUMENT REMAINING IN THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7882318 ↗