EIT PLIF cage PUI40802Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557778395), received between Sep 17, 2025 and Sep 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2025Entrapment of Device; Device-Device Incompatibility; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT PATIENT UNDERWENT A SPINAL FUSION (L4/5) FOR STENOSIS ON (B)(6) 2025. DURING THE SURGERY TO REPLACE A CAGE (INSERTED ON (B)(6) 2025), A CONDUIT WAS INSERTED INTO L4/5. THE ONE ON THE RIGHT SIDE WAS INSERTED WITHOUT ANY PROBLEMS, BUT THE ONE ON THE LEFT SIDE WAS PLACED ALMOST DIRECTLY TO THE SIDE, SO THE SURGEON TRIED TO REMOVE THE CAGE TO MAKE CORRECTIONS, BUT THE CONNECTION POINT WITH THE HOLDER WAS NOT VISIBLE BECAUSE THE CAGE WAS POSITIONED TO THE SIDE. THE SURGEON CHECKED WITH A SINGLE SHOT USING FLUOROSCOPY AND TRIED TO GRASP THE CAGE WITH FORCEPS, BUT WAS UNABLE TO GRASP IT PROPERLY, AND THE CAGE MOVED TO THE UPPER LEFT LATERAL SIDE OF THE VERTEBRAL BODY, REACHING A POSITION HIGH IN THE CENTER OF THE L4 VERTEBRAL BODY AND DEEP ENOUGH TO REACH THE CENTER OF THE L4 VERTEBRAL BODY. THE SURGEON ATTEMPTED TO RETRIEVE IT, BUT DETERMINED THAT THIS WOULD BE DIFFICULT, SO THEY CLOSED THE WOUND. INSTEAD, THE SURGEON PLACED A NEW CAGE ON THE LEFT SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY MINUTES OF DELAY. PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 23072851 ↗