Tritanium PL 48951102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327295108), received between Nov 4, 2022 and May 21, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Insert” (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. 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.

• InjuryMay 21, 2025Difficult to Insert; Mechanical Jam; Difficult to Insert; Mechanical Jam

  IT WAS REPORTED THAT ONE TRITANIUM POSTERIOR LUMBAR CAGE BECAME JAMMED AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT INTRA-OPERATIVELY, AND THAT A SECOND TRITANIUM POSTERIOR LUMBAR CAGE MIGRATED INTRA-OPERATIVELY, "PARTIALLY ENTERED THE VERTEBRAL BODY", AND WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY BY INSERTING A THIRD CAGE LATERAL FROM THE INITIAL APPROACH. THIS REPORT IS FOR THE CAGE THAT BECAME JAMMED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22061045 ↗
• MalfunctionNov 4, 2022Improper or Incorrect Procedure or Method; Migration; Improper or Incorrect Procedure or Method; Migration

  IT WAS REPORTED THAT A TRITANIUM PL POSTERIOR LUMBAR CAGE MIGRATED ANTERIORLY DURING FINAL IMPACTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15728057 ↗