EIT PLIF cage PUI80906Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04260557779965), received between May 26, 2022 and May 6, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionMay 6, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN INTERBODY FUSION (L2-3) PROCEDURE FOR STENOSIS, THE CAGE WAS FILLED WITH BONES, PLACED ON THE INSERTER, AND INSERTED INTO THE INTERBODY SPACE. THE CAGE COULD NOT BE REMOVED DESPITE MULTIPLE ATTEMPTS OVER 10 MINUTES, REQUIRING REMOVAL FROM THE BODY WITH SIGNIFICANT FORCE. AFTER REINSERTION, THE CAGE AGAIN COULD NOT BE DETACHED IN THE INTERBODY, RESULTING IN APPROXIMATELY A 30-MINUTE SURGICAL DELAY. THE CAGE WAS THEN REPLACED WITH ANOTHER DEVICE, WHICH FUNCTIONED AS INTENDED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25104801 ↗
• MalfunctionMay 26, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CONDUIT STRAIGHT INSERTER BROKE IN SURGERY. THE SURGEON INSERTED THE CAGE INTO THE DISC SPACE AND VERIFIED WITH C ARM THAT IT WAS IN PLACE. THE SURGEON TRIED TO UNTHREAD THE INSERTER FROM THE CAGE AND IT WOULD NOT RELEASE THE CAGE. THE SURGEON EXTRACTED THE CAGE AND INSERTER FROM THE DISC SPACE. THE KNOB CAME LOOSE FROM THE INSERTER AND FELL ONTO THE FLOOR. THE CAGE WHICH WAS LOADED WITH VIVIGEN WOULD NOT RELEASE FROM THE INSERTER. THE THREADED SHAFT WAS HOLDING THE CAGE ON. IT APPEARS THAT THE WELD BROKE. IT WAS COMPACTED INTO THE ENTIRE CAGE. THE SURGEON USED ANOTHER INSERTER IN THE SET. THERE WAS NO PATIENT CONSEQUENCE AND SURGERY WAS DELAYED BY ABOUT 3 MINS. THIS REPORT INVOLVES ONE EIT PLIF, H 9MM, 8°, 26/9. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518632 ↗