Tritanium PL 48951076Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327117523), received between Dec 10, 2018 and Dec 10, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2020Migration; Migration

  IT WAS REPORTED THAT DURING INTRA-OPERATIVE PLACEMENT OF A TRITANIUM PL CAGE, THE CAGE FELL ANTERIOR TO THE VERTEBRAL BODY. THE SURGEON THEN ATTEMPTED TO REMOVE THE CAGE FROM BEHIND BUT COULD NOT. THE SURGERY WAS COMPLETED BY LEAVING THE CAGE IN PLACE. REVISION SURGERY IS NOT PLANNED AT THIS TIME BUT THE POSSIBLY WILL BE REVISITED IN THE FUTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984703 ↗
• MalfunctionDec 10, 2018Fracture

  IT WAS REPORTED THAT THE CAGE FRACTURED POST-OPERATIVELY. NO ADVERSE CONSEQUENCE TO THE PATIENT WAS REPORTED. AS PER CONVERSATION WITH THE SURGEON, HE THINKS THAT THE FRACTURE COULD HAVE BEEN INITIATED DURING INSERTION WHICH MIGHT HAVE CONTRIBUTED TO THE EVENT.

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

  MAUDE report 8146640 ↗