EIT TLIF cage TUI81232Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04260557776605), received between Oct 21, 2020 and Oct 21, 2020 — 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.

• MalfunctionOct 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE SURGEON HAD TO ABANDON USING THE CAGE AND INSERTION INSTRUMENTS BECAUSE OF THEIR INABILITY TO MAINTAIN A STRAIGHT LINE. THE THREAD THAT CONNECTED THE SILVER HANDLE TO THE TIGHTENING DEVICE FOR THE CAGE WAS WORN AND WAS A WEAK POINT IN THE INSERTION DEVICE MECHANISM. THE RATCHETED OR TENSION ATTACHMENT FOR THE CAGE CAUSED A DANGEROUS MISALIGNMENT OF THE BANANA CAGE DURING INSERTION. ONCE THE CAGE HAD BEEN ATTACHED TO THE INSERTION DEVICE IN THE CORRECT FASHION THE SURGEON SHOULD HAVE BEEN ABLE TO INSERT IT IN A DIRECT LINE WITH THE INSTRUMENT. THE ATTACHMENT OF THE CAGE WAS NOT ABLE TO HOLD THE STRAIGHT ALIGNMENT ,AND UPON INSERTION THE CAGE FLEXED AND WENT INTO THE SPINAL CANAL. IT IS CRUCIAL ESPECIALLY FOR MIS THAT THE CAGE BE ABLE TO BE INSERTED IN THE EXACT LINE THAT THE SURGEON PLACED IT IN. ONCE IN THE CORRECT POSITION OF THE DISC SPACE IT CAN RELEASE THE TENSION, THE HANDLE CAN MOVE MEDIALLY AND CAN GET IN THE DESIRED POSITION. WEAR OF THE INSERTION DEVICE CREATED AN UNSAFE SITUATION FOR THE PATIENT. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. ANOTHER CAGE AND INSE

  Patient problems: Not Applicable

  MAUDE report 10712257 ↗