Tritanium PL 48950106Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327117417), received between Jul 24, 2017 and May 17, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 17, 2022Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT PATIENT WAS REVISED TO ADDRESS A TRITANIUM PL CAGE WHICH BACKED OUT APPROXIMATELY SIX WEEKS POST-OPERATIVELY. THE PATIENT ALSO REPORTED EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 14418927 ↗
• InjuryOct 29, 2019Device Dislodged or Dislocated; Migration; Migration

  A PHYSICIAN REPORTED THAT APPROXIMATELY ONE MONTH AFTER A L2/3/4/5 PLIF IMPLANTATION, THE PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A BACKED-OUT TRITANIUM PL CAGE. REVISION SURGERY WAS PERFORMED TO REMOVE THE CAGE AND EXTEND THE FIXATION RANGE AS THE BONE HAD COLLAPSED.

  Patient problems: Injury

  MAUDE report 9252407 ↗
• InjurySep 4, 2019Migration

  IT WAS REPORTED THAT A TRITANIUM PL CAGE MIGRATED POST OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY AND THE CAGE WAS REPLACED.

  Patient problems: Injury

  MAUDE report 8961788 ↗
• MalfunctionJul 24, 2017Fracture; Break; Detachment Of Device Component; Fracture

  IT WAS REPORTED THAT THE SURGEON INSERTERED IMPLANT INTO THE DISC SPACE THEN ATTEMPTED TO ROTATE THE CAGE FOR PROPER ANATOMICAL ALIGNMENT AND THE BACK 1/3 PART OF THE CAGE SHEERED OFF.

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

  MAUDE report 6737516 ↗