T2 STRATOSPHERE™ Expandable Corpectomy System 436013A (UDI 00643169663114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169663114), received between Jan 29, 2021 and Aug 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 14, 2023Break; Break

  INFORMATION WAS RECEIVED FROM HEALTH CARE PROFESSIONAL VIA MANUFACTURING REPRESENTATIVE REGARDING A PATIENT UNDERGOING UNKNOWN SPINE SURGERY. IT WAS REPORTED THAT IMPLANT WIND UP TEETH BROKEN DURING EXPANSION OF DEVICE. NO ISSUE WITH ENDCAP BEING ATTACHED TO IMPLANT. NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED DUE TO THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP THAT PROCEDURE USED IN THIS EVENT WAS C5 CORPECTOMY, PRE OP DIAGNOSIS DETAILS OF THIS EVENT WAS PREVIOUS INFECTION IN C5 VERTEBRAE. PROCEDURE WAS EXTENDED BY 20 MINUTES DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17538685 ↗
• MalfunctionOct 10, 2022Mechanics Altered; Mechanics Altered

  INFORMATION WAS RECEIVED FROM MULTIPLE RESOURCES(DISTRIBUTOR(DIS), HEALTHCARE PROFESSIONAL (HCP)) VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICES USED IN AN UNKNOWN SPINAL THERAPY. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO TURN THE LOCKING RING TO LOCK THE CAGE. ALSO, THE LOCKING DRIVER WOULD NOT ENGAGE THE SCREW TO LOCK THE CAGE. THE INSERTER WOULD NOT DISENGAGE FROM THE IMPLANT INSITU. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THIS EVENT AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE IMPLANT CAME IN CONTACT WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15572015 ↗
• MalfunctionJan 29, 2021Activation Failure; Activation Failure

  INFORMATION WAS RECEIVED FROM A CONSUMER VIA FIELD REPRESENTATIVE A PATIENT WHO UNDERGONE SPINAL THERAPY WITH UNKNOWN INDICATION. IT WAS REPORTED THAT THE INSERTER LOCK DOESN¿T WORK CORRECTLY AND GETS STUCK. REMOVAL TOOL TIP WAS BENT WHILE TRYING TO REMOVE AN ENDCAP AND CENTERPIECE WOULD NOT EXPAND WHEN MET WITH RESISTANCE IN THE DISC SPACE. NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THE CASE WAS A C6 CORPECTOMY AND THE CONSUMER WANTED TO USE STRATOSPHERE. THERE WAS SURGICAL DELAY OF 45 MINUTES DUE TO REPORTED PRODUCT MALFUNCTION. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11249730 ↗