Tritanium PL 48950100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327117295), received between Feb 13, 2017 and May 26, 2017 — classified as 1 injury, 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. 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 26, 2017Migration or Expulsion of Device; Expulsion; Migration or Expulsion of Device

  IT WAS REPORTED THAT; SURGEON TEXTED ME X-RAY ON (B)(6) 2017 OF PATIENT IMPLANT SITE AT 6 WEEK POST-OP VISIT SHOWING AN EXPULSED CAGE AT L3/L4. PATIENT IS CURRENTLY ASYMPTOMATIC. HE NOTIFIED ME THAT HE HAD SCHEDULED HER FOR REVISION/REMOVAL ON (B)(6) 2017. DATE OF ORIGINAL SURGERY WAS (B)(6) 2017. UPDATE 5/17/2017: PATIENT RECEIVED REVISION SURGERY ON (B)(6) 2017.

  Patient problems: Failure of Implant; Injury

  MAUDE report 6595236 ↗
• MalfunctionFeb 13, 2017Break; Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT THE CAGE BROKE DURING SPINE SURGERY DUE TO PATIENT IN PAIN. ADDITIONAL DEVICE AVAILABLE FOR REPLACEMENT OF BROKEN CAGE. NO ADVERSE CONSEQUENCES OR DELAY. SALES REP NEED REPLACEMENT. UPDATE 1/24/2017: "SURGERY WAS BC OF PAIN MOST LIKELY¿ANYWAYS, THE CAGE BROKE DURING INSERTION DUE TO THE SURGEON USING A ROTATION TECHNIQUE WHICH IS WHEN YOU PUT IN ON SIDE AND ROTATE TO ITS PROPER CRANIAL/CAUDAL POSITION"

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

  MAUDE report 6326956 ↗