CASPIAN® Spinal System 1101-04032FRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888857014374), received between Sep 9, 2020 and Sep 9, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionSep 9, 2020Material Separation; No Apparent Adverse Event; Material Separation; No Apparent Adverse Event

  A PHYSICIAN REPORTED THAT A TWO SCREWS, "FRACTURED FROM THE HEAD," POST-OPERATIVELY. THE PATIENT HAS UNDERGONE REVISION SURGERY. THIS REPORT WILL CAPTURE THE SECOND OF TWO SCREWS.

  Patient problems: Injury; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10507944 ↗
• InjurySep 9, 2020Fracture; Material Separation; Fracture; Material Separation

  A PHYSICIAN INITIALLY REPORTED TWO POST-OPERATIVE SCREW FRACTURES. HOWEVER, SUBSEQUENT INVESTIGATION CLARIFIED THAT THE EVENT RELEVANT TO THIS PATIENT WAS A ROD FRACTURE. IT WAS REPORTED THAT THE ROD FRACTURED AND PROTRUDED THROUGH THE SKIN. THE PATIENT HAS UNDERGONE REVISION SURGERY.

  Patient problems: Injury; Pain; Rupture

  MAUDE report 10507926 ↗