Tritanium PL 48955116Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327118094), received between Mar 12, 2018 and Apr 19, 2024 — 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 19, 2024Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM POSTERIOR LUMBAR CAGE FRACTURED DURING INSERTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 10 MINUTE SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vertebral Fracture

  MAUDE report 19144567 ↗
• InjuryOct 8, 2019Migration or Expulsion of Device; Migration; Migration

  A PHYSICIAN REPORTED REVISION SURGERY TO EXPLANT A MIGRATED TRITANIUM PL CAGE AND A FRACTURED ES2 INTEGRATED BLADE SCREW. THE PATIENT REPORTED EXPERIENCING PAIN. THIS REPORT CAPTURES THE TRITANIUM PL CAGE.

  Patient problems: Injury; Pain

  MAUDE report 9167052 ↗
• MalfunctionMar 12, 2018Fracture; Break; Fracture; Material Fragmentation

  IT WAS REPORTED THAT A SURGEON WAS PERFORMING A SINGLE LEVEL T-LIFT, L2-L3. DISCECTOMY WAS COMPLETED WITH NO ISSUE. THE SURGEON PREPARED END PLATES AND USED PROPER INSERTER TO INSERT INTERBODY BY LIGHTLY TAPPING WITH MALLET INSERTER TO PUT IT IN PROPER POSITION. SURGEON CHECKED FLUORO AND OBSERVED INTERBODY APPEARED TO TURN OBLIQUELY 60 DEGREES. SURGEON REMOVED THE INSERTER WITH INTERBODY AND THE TOP 1/3 ATTACHED TO THE INSERTER, WHILE THE REMAINING 2/3 SHATTERED IN PIECES IN THE PATIENT'S BODY. ALL PIECES WERE REMOVED AND SURGEON TOOK ADDITIONAL FLUORO TO CONFIRM ALL PARTICLES WHERE REMOVED. SURGEON COMPLETED SURGERY WITH A NEW DEVICE AND COMPLETED THE SURGERY SUCCESSFULLY. THERE WAS A REPORTED SURGICAL DELAY OF 1 HOUR 15 MINUTES. THERE WERE NO ADVERSE HEALTH CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7331387 ↗