Tritanium PL 48951096Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327117561), received between Dec 8, 2017 and Apr 2, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Migration; Migration

  A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT REVISION SURGERY TO ADDRESS A TRITANIUM PL CAGE THAT MIGRATED POST-OPERATIVELY. THE PATIENT REPORTED EXPERIENCING PAIN.

  Patient problems: Pain

  MAUDE report 21758582 ↗
• MalfunctionSep 12, 2019Fracture

  A PHYSICIAN REPORTED THAT A TRITANIUM PL CAGE PLACED AT L5 TO S1 WAS FOUND TO BE FRACTURED APPROXIMATELY ONE YEAR AFTER IMPLANTATION. PATIENT HAS BEEN EXPERIENCING, ¿SOME INCREASE IN AXIAL PAIN.¿ REVISION SURGERY IS NOT PLANNED AT THIS TIME; PHYSICIAN HAS SCHEDULED A FOLLOW-UP X-RAY WITH THE PATIENT IN THREE MONTHS.

  Patient problems: Pain

  MAUDE report 9007945 ↗
• MalfunctionAug 16, 2018Mechanical Jam; Mechanics Altered

  IT WAS REPORTED THAT THE STEERABLE INSERTER LOCKING MECHANISM WAS STUCK, PREVENTING THE TIP FROM ARTICULATING. THERE WAS NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT, THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING A STRAIGHT INSERTER, AND THERE WAS NO SURGICAL DELAY.

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

  MAUDE report 7789689 ↗
• MalfunctionApr 19, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT IN A FOLLOW UP CT SCAN OF A PATIENT WHO HAD SURGERY ABOUT THREE MONTHS AGO, THE DOCTOR CONFIRMED THAT THE CAGE WAS BROKEN BETWEEN THE VERTEBRAL BODIES. THE PATIENT DID NOT HAVE AN ADVERSE EVENT AND A REVISION SURGERY WAS NOT PLANED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7445134 ↗
• InjuryDec 8, 2017Fracture; Material Integrity Problem; Fracture; Material Integrity Problem

  IT WAS REPORTED THAT PLIF WAS DONE AT L3-5. WHEN INSERTING THE CAGE IN THE PROCEDURE OF THE MONOPOTAL PLF AND STRAIGHTENING THE DIAGONAL CAGE USING THE IMPACTOR, IT BROKE AT THE GRIP PORTION BEHIND THE CAGE. AFTER THAT, THE REMAINED CAGE WAS TRIED TO BE REMOVED WITH PUNCH, BUT THE CAGE WAS BROKEN AND ONLY THE FRAGMENTS WERE REMOVED, THEREFORE, THE VERTEBRAE WAS SCRAPED AND MADE SPADE IN THE CAGE PART AND IT WAS REMOVED. AFTER THAT, THE CAGE WAS IMPLANTED WITH BIPOLAR PLF AND THE OPERATION WAS SUCCEEDED.

  Patient problems: Injury

  MAUDE report 7099457 ↗