Tritanium PL 48954116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327117981), received between Feb 10, 2017 and Jul 2, 2024 — classified as 2 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2024Migration; Migration

  B5: A PATIENT WAS REVISED TO ADDRESS A MIGRATED TRITANIUM PL CAGE AT L4/L5 APPROXIMATELY FOUR MONTHS AFTER IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19656398 ↗
• InjuryNov 21, 2017Fracture

  IT WAS REPORTED THAT; LUMBAR CAGE FRACTURED IN HALF INSITU AT L5-S1. AS A RESULT, PATIENT WAS BROUGHT BACK FOR REVISION ALIF SURGERY.

  Patient problems: Failure of Implant; Injury; Pain

  MAUDE report 7049713 ↗
• MalfunctionFeb 10, 2017Break; Material Fragmentation; Material Integrity Problem; Break; Material Integrity Problem

  IT IS REPORTED THAT THE SURGEON DID A COUPLE TAPS DURING INSERTION OF THE CAGE AND TRIED TO TURN AND STEER THE CAGE. THE NOSE OF THE CAGE WAS IN THE DISC SPACE WAS UNDER LOAD AND THE REST OF THE CAGE WAS NOT IN. WHEN ROTATING AND STEERING THE CAGE, IT GAVE WAY BEHIND THE NOSE AND IT BROKE INTO MULTIPLE FRAGMENTS THAT DID NOT FALL IN THE PATIENT CAVITY. ALL FRAGMENTS WERE RETRIEVED. USED 1 MM SMALLER SIZED CAGE TO COMPLETE THE PROCEDURE (10 MM) PROCEDURE WAS COMPLETED SUCCESSFULLY. NO ADVERSE CONSEQUENCES OF THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6322395 ↗