Tritanium PL 48955106Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327118087), received between Nov 8, 2016 and Jul 27, 2021 — classified as 3 injuries, 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2021Migration; Migration

  IT WAS REPORTED THAT A TRITANIUM PL CAGE AT L4/5 MIGRATED APPROXIMATELY 9 MONTHS POST-OPERATIVELY. DURING REVISION SURGERY TO REMOVE THE CAGE, IT WAS NOTICED THERE WAS ALSO A LOOSE TRIO PEDICLE SCREW WHICH SUBSEQUENTLY WAS REMOVED. THE PATIENT HADN'T FUSED AND WAS EXPERIENCING PAIN. THIS REPORT CAPTURES THE CAGE.

  Patient problems: Pain

  MAUDE report 12229682 ↗
• MalfunctionDec 10, 2020Fracture; Fracture

  IT WAS REPORTED THAT WHEN 'THE SCRUB TECH OPENED THE STERILE TRITANIUM PL CAGE IT WAS BROKEN/BENT IN THE PACKAGE' INTRA-OPERATIVELY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984610 ↗
• MalfunctionDec 11, 2019Fracture; Fracture

  IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED DURING INTRA-OPERATIVE PLACEMENT AT THE L4/5 LEADING TO A 10 MINUTE SURGICAL DELAY. THE PHYSICIAN REPORTED THAT SOME FRAGMENTS COULD NOT BE RETRIEVED AND REMAINED IN THE SURGICAL SITE. THE SURGERY WAS SUCCESSFULLY COMPLETED BY IMPLANTING A NEW CAGE IN A MORE POSTERIOR POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9454606 ↗
• MalfunctionJul 25, 2019Fracture; Break; Fracture

  IT WAS REPORTED THAT THE SURGEON DID NOT LIKE THE TRAJECTORY OF THE TRITANIUM PL CAGE AND THAT WHILE REPOSITIONING THE IMPLANT INTO THE PATIENTS' DISC SPACE, THE IMPLANT BROKE RESULTING IN A 3 MINUTE DELAY TO OBTAIN ANOTHER IMPLANT. NO ADVERSE CONSEQUENCES TO THE PATIENT. AND SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8826444 ↗
• MalfunctionJan 31, 2019Break; Fracture; Material Fragmentation; Fracture

  IT WAS REPORTED THAT THE CAGE WAS FRACTURED WHILE REMOVING TO REPOSITION IT INTO L5/S1 DISC SPACE. ALL BROKEN FRAGMENTS WERE REMOVED. SURGICAL DELAY OF 45 MINUTE WAS REPORTED. THE SURGERY WAS COMPLETED USING ANOTHER CAGE OF IDENTICAL SIZE. NO ADVERSE CONSEQUENCES TO THE PATIENT WAS REPORTED.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 8292363 ↗
• MalfunctionSep 12, 2018Break; Fracture; Fracture

  IT WAS REPORTED THAT DURING A REVISION OF A DORSAL STABILIZATION SURGERY, THE SURGEON HAMMERED A CAGE IN WHICH GOT STUCK AND COULD NOT BE HAMMERED ANY FURTHER. CONSISTENT USE OF THE IMPACTOR LED TO THE BREAKAGE. BOTH FRAGMENTS COULD BE SAFELY REMOVED. ANOTHER CAGE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7870650 ↗
• MalfunctionMay 3, 2018Break; Fracture

  IT WAS REPORTED THAT WHILE INSERTING THE PL CAGE WITH THE CORRECT INSERTER, IT BROKE IN THE MIDDLE. THE NOSE OF THE CAGE WAS JUST INSIDE THE DISC SPACE WHEN THE SURGEON ROTATED THE CAGE ABOUT 20 DEGREES TO OBTAIN BETTER INSERTION ALIGNMENT. WHEN THE NEXT X-RAY WAS TAKEN, IT WAS NOTICED THAT THE CAGE HAD FRACTURED DOWN THE MIDDLE. ALL PIECES OF THE CAGE WERE REMOVED. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7482350 ↗
• MalfunctionMay 2, 2018Fracture; Break; Fracture

  IT WAS REPORTED THAT THE IMPLANT BROKE DURING A PROCEDURE. PART OF THE IMPLANT REMAINS IMPLANTED IN THE PATIENT. THERE WAS LESS THAN 20 MINUTES SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7479072 ↗
• InjuryApr 11, 2018Migration; Device Dislodged or Dislocated; Migration

  IT WAS REPORTED THAT A CAGE THAT WAS IMPLANTED 4 MONTHS DISLODGED FROM ITS ORIGINAL POSITION, REQUIRING REVISION SURGERY TO REMOVE THE INTERBODY.

  Patient problems: Injury; No Code Available

  MAUDE report 7423395 ↗
• MalfunctionMar 7, 2018Material Deformation

  IT IS REPORTED THAT THE CAGE DEFORMED UPON INSERTION. THE CAGE REMAINS IMPLANTED IN THE PATIENT . NO ADVERSE CONSEQUENCES TO THE PATIENT IS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7322754 ↗
• MalfunctionJul 10, 2017Fracture; Break; Fracture

  IT WAS REPORTED THAT; CAGE BROKE WHEN IMPACTING CAGE INTO DISK SPACE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6699428 ↗
• MalfunctionApr 10, 2017Break; Fracture; Difficult to Insert; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT THE CAGE FRACTURED DURING INSERTION.

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

  MAUDE report 6478126 ↗
• InjuryNov 8, 2016Device Dislodged or Dislocated; Malposition of Device; Device Dislodged or Dislocated

  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 STRYKER REPRESENTATIVE.

  Patient problems: Fall; Injury; Pain

  MAUDE report 6085169 ↗