Tritanium PL 48955096Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327118070), received between Aug 15, 2016 and Mar 25, 2022 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fracture” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED APPROXIMATELY TWO-YEARS POST-OPERATIVELY. REVISION SURGERY HAS NOT BEEN SCHEDULED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13902438 ↗
• MalfunctionJun 4, 2021Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED DURING IMPLANTATION. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE BROKEN COMPONENT REMAINS IN THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY FOLLOWING A 10-MINUTE DELAY. REVISION SURGERY WILL NOT BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939190 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO TRITANIUM PL CAGES FRACTURED AT L5-S1 INTRA-OPERATIVELY DURING IMPACTION. THIS CONTRIBUTED TO A 20 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND ALL FRACTURED FRAGMENTS WERE REMOVED FROM THE SURGICAL SITE. THIS REPORT CAPTURES THE SECOND OF TWO CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10417604 ↗
• MalfunctionAug 17, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO TRITANIUM PL CAGES FRACTURED AT L5-S1 INTRA-OPERATIVELY DURING IMPACTION. THIS CONTRIBUTED TO A 20 MINUTE SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND ALL FRACTURED FRAGMENTS WERE REMOVED FROM THE SURGICAL SITE. THIS REPORT CAPTURES THE FIRST OF TWO CAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10417578 ↗
• MalfunctionOct 23, 2019Fracture

  A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY DURING CAGE INSERTION LEADING TO A 5 MINUTE SURGICAL DELAY.

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

  MAUDE report 9229757 ↗
• MalfunctionApr 26, 2019Fracture; Material Integrity Problem; Material Integrity Problem

  THE PHYSICIAN REPORTED A TRITANIUM PL CAGE WHICH FRACTURED AT L5-S1. THE PATIENT IS DOING WELL AND THE PHYSICIAN DOES NOT ANTICIPATE PERFORMING A REVISION SURGERY.

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

  MAUDE report 8558002 ↗
• MalfunctionJun 13, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING TLIF PROCEDURE THE CAGE BROKE APART INTO PIECES WHILE INSERTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6638805 ↗
• MalfunctionOct 10, 2016Break; Material Integrity Problem; Break; Fracture; Failure to Align; Material Integrity Problem

  IT WAS REPORTED THAT; WHILE INSERTING THE DEVICE IN A COLLAPSED DISC SPACE THE BACK OF THE IMPLANT FRACTURED. THE INSTRUMENT TO IMPLANT INTERFACE WAS MISALIGNED ABOUT 15 DEGREES AND WASN'T STRAIGHT VERTICAL DUE TO THE ANATOMY. WHILE THE SURGEON WAS MALLETING INTO DISC SPACE THE IMPLANT FRACTURED/SHEARED ABOUT 7MM FROM THE PROXIMAL END INTO THE TEETH OF THE CAGE. THERE WERE NO SAFETY ISSUES TO THE PATIENT, SO SURGEON LEFT THE CAGE IMPLANTED. THE BROKEN PIECE WAS REMOVED AND A BONE FILLER WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6015259 ↗
• MalfunctionAug 15, 2016Break; Fracture; Failure to Advance; Fracture

  IT WAS REPORTED THAT THE SURGEON WAS DOING A HIGH S1 CASE AND HAD TROUBLE ADVANCING THE CAGE, THE SURGEON HAD TO TWIST THE CAGE TO INSERT; WHILE TWISTING THE CAGE DURING INSERTION, THE CAGE BROKE ALONG THE SKINNY PART OF THE GRAFT WINDOW (WAS NOT IN THE DISC SPACE). IT APPEARS THAT WHEN TWISTING THE CAGE, THE NOSE GOT CAUGHT IN THE SACRUM AND THE CAGE BROKE. THE SURGEON WAS PERFORMING A REVISION OF A COMPETITOR'S PRODUCT. SAME SIZE CAGE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 5877365 ↗
• MalfunctionAug 15, 2016Break

  IT WAS REPORTED THAT; THE SURGEON SHAVED THE DISC SPACE TO 9MM. THE CAGE WAS USED ON THE 11MM INSERTER. THE REP CONFIRMED THE IMPLANT WAS ON FIRMLY. THE SURGEON WAS VERY CAUTIOUS WHEN HITTING THE INSERTER WITH THE MALLET. UPON INSERTION, THE GRAFT WAS INSERTED HALF WAY INTO THE DISC SPACE AND THE GRAFT BROKE WHILE IN THE PATIENT. 2/3RDS OF THE GRAFT THAT BROKE OFF INTO THE PATIENT WAS IMPACTED AND LEFT INSIDE THE PATIENT. THE PIECE THAT WAS ON THE INSERTER WILL BE RETURNED. FIRST TIME, THE SURGEON USED TRITANIUM AND NOTHING WAS DONE OUT OF THE ORDINARY. HE DID NOT INSERT THE GRAFT UNDER DISTRACTION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5877279 ↗