Tritanium PL 48954096Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327117967), received between Apr 10, 2018 and Oct 27, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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.

• MalfunctionOct 27, 2020Fracture; Fracture

  IT WAS DISCOVERED DURING PATIENT MONITORING THAT A TRITANIUM PL CAGE FRACTURED POST-OPERATIVELY. THE PATIENT HAS REPORTED PERIODIC PAIN IN THE LUMBOSACRAL REGION. REVISION SURGERY WILL NOT BE PERFORMED.

  Patient problems: Pain

  MAUDE report 10742782 ↗
• MalfunctionApr 10, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT UPON INSERTION OF THE CAGE AT THE L5-S1 LEVEL BROKE IN TWO PIECES AS THE CAGE WAS ADVANCING INTO THE DISC SPACE. THE SURGEON WAS FOLLOWING CORRECT INSERTION GUIDELINES AND WAS NOT HANDLING IT AGGRESSIVELY OR USING EXCESSIVE FORCE. THE SURGEON WAS ABLE TO DISTRACT THE DISC SPACE ENOUGH TO RETRIEVE THE BROKEN PIECE AND HE THEN PLACED ANOTHER CAGE OF THE SAME SIZE INTO THE SPACE WITH NO ISSUES. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7410612 ↗