Tritanium PL 48955086Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327118063), received between Nov 8, 2016 and Oct 28, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 28, 2018Fracture

  IT WAS REPORTED THAT THE CAGE FRACTURED POST OP AFTER LIFTING A HEAVY OBJECT. REPORTED THAT REVISION WILL BE NEEDED IN THE FUTURE.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8011504 ↗
• InjuryNov 28, 2016Fracture; Collapse; Fracture

  IT WAS REPORTED THAT; CAGE APPEAR TO COLLAPSE IN SITU.

  Patient problems: Injury; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 6130463 ↗
• MalfunctionNov 8, 2016Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT; THE SURGEON PHONED TO SAY HIS PATIENT HAD SUFFERED A FALL 2 WEEKS POSTOPERATIVELY AND AS A CONSEQUENCE HAS LEG PAIN. THE SURGEON REPORTED THAT ON X-RAY THE CAGES APPEARS TO HAVE RETRO PULSED OUT OF THE DISC SPACE. THE X-RAYS HAVE NOT YET BEEN VIEWED BY THE REP.

  Patient problems: Fall; No Known Impact Or Consequence To Patient; Pain

  MAUDE report 6085162 ↗