EIT TLIF cage TUI80928Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557776414), received between Aug 4, 2025 and Aug 4, 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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THE PATIENT WAS UNDERGOING A POSTERIOR LUMBAR INTERBODY FUSION (L4/5) FOR DEGENERATIVE SCOLIOSIS ON (B)(6) 2025. IN THE SURGERY, THE SURGEON INSERTED A CONDUIT CURVED BETWEEN THE VERTEBRAL BODIES VIA A TLIF APPROACH FROM THE RIGHT SIDE AT L4/5. WHEN THE PLACEMENT WAS CHECKED USING A C-ARM, THE LATERAL VIEW SHOWED IT TO BE IN THE NORMAL POSITION. HOWEVER, IN THE FRONT VIEW, IT WAS CONFIRMED THAT THE CAGE WAS INSTALLED QUITE CLOSE TO THE INSERTION SIDE (RIGHT SIDE). WHEN THE SURGEON TRIED TO MOVE THE CAGE BACK INTO ITS NORMAL POSITION BY APPLYING A SMALL AMOUNT OF IMPACT, THE CAGE DEVIATED FROM THE SPACE BETWEEN THE VERTEBRAE AND SLID DOWN NEAR THE FRONT OF THE VERTEBRAE. ALTHOUGH IT WAS DIFFICULT TO FIND WHERE THE CAGE WAS INSIDE THE BODY, THE LOCATION WAS IDENTIFIED BY CHECKING THE FLUOROSCOPIC IMAGES WITH A C-ARM. THE SURGEON WAS ABLE TO REMOVE IT BY USING A SMALL HOOK-TIPPED STEEL TOOL OWNED BY THE HOSPITAL TO HOOK THE CAGE AND PULL IT UP. THE SURGEON THEN ATTEMPTED TO INSERT THE CAGE AGAIN AT L4/5, BUT WAS UNABLE TO FEEL IT WAS PLACED STABLY, SO HE ULTIMATELY FILLED THE L4/5 SPACE WITH BONE GRAFT INSTEAD. IN ADDITION, THE SURGEON PERFORMED FIXATION BY FIRMLY SPRE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22704953 ↗