CASPIAN® Spinal System 1101-04536FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857015395), received between Dec 7, 2020 and Dec 7, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA MINI POLYAXIAL SCREWS FRACTURED AT THE SHANK APPROXIMATELY 1 YEAR AND 3 MONTHS POST-OPERATIVELY. THE PATIENT HAD ACHIEVED FUSION. THE SCREWS WERE REMOVED AND REPLACED AND THE CONSTRUCT WAS EXTENDED TO ACHIEVE FURTHER FUSION. THIS REPORT CAPTURES THE SECOND OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960669 ↗
• InjuryDec 7, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO MESA MINI POLYAXIAL SCREWS FRACTURED AT THE SHANK APPROXIMATELY 1 YEAR AND 3 MONTHS POST-OPERATIVELY. THE PATIENT HAD ACHIEVED FUSION. THE SCREWS WERE REMOVED AND REPLACED AND THE CONSTRUCT WAS EXTENDED TO ACHIEVE FURTHER FUSION. THIS REPORT CAPTURES THE FIRST OF TWO SCREWS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960663 ↗