T.L.I.F. 274284000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034191928), received between Aug 19, 2022 and Aug 19, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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 18, 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 19, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WAS PERFORMING A L5-S1 POSTERIOR FUSION WITH INTERBODY CAGE. WHILE SURGEON WAS PREPARING THE DISC SPACE FOR INSERTION OF THE INTERBODY CAGE, HE WAS USING THE PITUITARY TO REMOVE THE DISC AND THE TIP OF THE PITUITARY BECAME BROKEN AT THE HINGE POINT. THE PITUITARY TIP REMAINED INTACT BUT THE TIP WAS NOW BENT ON AN ANGLE. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCE. NO OTHER MEDICAL INTERVENTION WAS NOT NEEDED. SURGEON HAD ANOTHER INSTRUMENT THAT WAS AVAILABLE TO USE AND THE SURGEON WAS ABLE TO SUCCESSFULLY PERFORM THE PLANNED PROCEDURE. THIS REPORT IS FOR ONE STRAIGHT SM BITE RONGEUR. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261718 ↗