T2 STRATOSPHERE™ Expandable Corpectomy System 436013A (UDI 00763000856243)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000856243), received between Jan 27, 2025 and May 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE PLATE WOULD NOT TURN. ADDITIONALLY, MULTIPLE INSTANCES OF THE CENTERPIECES WERE NOTED TO HAVE LOCK SET SCREWS THAT SEEMED TO BE CROSS-THREADED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058211 ↗
• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE PLATE WOULD NOT TURN. ADDITIONALLY, MULTIPLE INSTANCES OF THE CENTERPIECES WERE NOTED TO HAVE LOCK SET SCREWS THAT SEEMED TO BE CROSS-THREADED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058210 ↗
• MalfunctionMay 21, 2025Material Deformation; Material Deformation

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). IT WAS REPORTED THAT THE LOCKING MECHANISM OF THE PLATE WOULD NOT TURN. ADDITIONALLY, MULTIPLE INSTANCES OF THE CENTERPIECES WERE NOTED TO HAVE LOCK SET SCREWS THAT SEEMED TO BE CROSS-THREADED. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058153 ↗
• MalfunctionMay 14, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT DURING A TRIAL WITH THE INSERTER, THE SET SCREWS OF THE CENTERPIECE DID NOT WORK PROPERLY, RENDERING THEM UNUSABLE FOR THE CASE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016412 ↗
• MalfunctionMar 10, 2025Mechanical Problem; Mechanical Problem

  INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING SPINAL THERAPY. IT WAS REPORTED THAT AT THE MOMENT OF PLACING THE IMPLANT, IT WAS OBSERVED THAT THE CENTRAL SCREW DID NOT FULFILL ITS FUNCTION OF KEEPING THE IMPLANT EXPANDED. AFTER REVIEWING THE IMPLANT, IT WAS CONCLUDED THAT IT WAS NOT FUNCTIONING CORRECTLY, SO IT WAS DECIDED TO TRY ANOTHER IMPLANT, WHICH WORKED WITHOUT ISSUES. IT WAS DETECTED THAT THE SCREW WAS EXCESSIVELY TIGHTENED AND DID NOT YIELD TO PERFORM THE REQUIRED FUNCTION. IT WAS DETERMINED THAT A NEW IMPLANT HAD TO BE USED SINCE THE ONE BEING PLACED PRESENTED THE FAILURE.. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21559099 ↗
• MalfunctionJan 27, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A CENTERPIECE USED FOR SPINAL THERAPY. IT WAS REPORTED THAT THE TWO SCREWS IN EXPANDABLE CORPECTOMY DEVICE RESPONSIBLE FOR LOCKING ITS EXPANSION AND CUSTOMIZED ENDPLATE MORPHOLOGY WAS STRIPPED AND WILL NOT TIGHTEN TO LOCK THE EXPANSION MECHANISM. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21239376 ↗