Tritanium PL 48953090Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327117851), received between Nov 14, 2016 and Jul 11, 2025 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO REMOVE A TRITANIUM PL CAGE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22481574 ↗
• MalfunctionJul 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE FRACTURED COMPONENTS WERE REMOVED FROM THE PATIENT, RESULTING IN A 30-60 MINUTE SURGICAL DELAY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22475056 ↗
• InjuryJun 6, 2018Migration or Expulsion of Device; Migration; Migration

  IT WAS REPORTED THAT 2 SCREWS PULLED OUT OF VERTEBRAL BODY AND INTERBODY CAGE MIGRATED FROM ORIGINAL POSITION. PATIENT REQUIRED REVISION SURGERY.

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 7573021 ↗
• MalfunctionApr 2, 2018Fracture

  IT WAS REPORTED THAT A CAGE APPEARED FRACTURED IN A FOLLOW-UP X-RAY. THE PATIENT HAD A L5-S1 FUSION ON (B)(6) 2016 AND IMAGES LOOKED NORMAL ON SEVERAL FOLLOW UP APPOINTMENTS. THE SURGEON SAID THAT THE PATIENT IS NOT SYMPTOMATIC.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7390489 ↗
• MalfunctionFeb 13, 2018Fracture; Split; Fracture

  AFTER A CAGE WAS INSERTED (L5-S1), FINAL X-RAY INDICATED THE CAGE SPLIT. THE SURGEON REMOVED THE POSTERIOR PORTION OF THE CAGE, LEAVING ANTERIOR PORTION IN THE DISC SPACE. ALL FRAGMENTS WERE SUCCESSFULLY RETRIEVED AND THERE WERE NO DELAYS OR ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7266684 ↗
• MalfunctionApr 5, 2017Break; Material Integrity Problem; Material Twisted/Bent; Break; Material Integrity Problem

  IT WAS REPORTED THAT; UPON IMPLANTING AN INTERBODY DEVICE THE CAGE BECAME TWISTED. THE SURGEON NOTICED IT, REMOVED THE IMPLANT AND A NEW CAGE WAS USED SUCCESSFULLY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 6460971 ↗
• MalfunctionFeb 20, 2017Break; Fracture; Fracture

  IT WAS REPORTED THAT; THE CAGE BROKE DURING INSERTION AND POSITIONING OF CAGE. THE CORRECT INSERTER (SIZE 11) WAS ALLEGEDLY THREADED ONTO CAGE AND IMPLANTED. THERE WAS NO REPORTED DELAYS OR ADVERSE EVENT OCCURRED DURING SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6344242 ↗
• MalfunctionNov 14, 2016Fracture; Break; Fracture

  IT WAS REPORTED THAT; WHILE ATTEMPTING TO INSERT A CAGE, THE CAGE BROKE INTO SEVERAL PIECES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6100929 ↗