Tritanium PL 48955126Recalls & reported problems
Stryker Corporation · Posterior Lumbar Cage · Class 2 · Implant
All models of Tritanium PL (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327118100), received between Jul 10, 2017 and Nov 21, 2025 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture2
- Migration2
- Device Dislodged or Dislocated1
Patient problems
- No Known Impact Or Consequence To Patient2
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryNov 21, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23622580 ↗InjuryApr 8, 2019Device Dislodged or Dislocated; Migration; Migration
IT WAS REPORTED THAT THE CAGE BACKED OUT POST-OPERATIVELY. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE CAGE WITH ALIF IMPLANT USING ANTERIOR APPROACH.
Patient problems: Injury; No Code Available
MAUDE report 8493429 ↗MalfunctionMay 2, 2018Break; Fracture
IT WAS REPORTED THAT WHILE INSERTING A CAGE (L4/5) WITH THE CORRECT INSERTER, IT BROKE IN THE MIDDLE OF THE CAGE. THE CAGE WAS ABOUT HALF WAY IN WHEN THE SURGEON TRIED TO SLIGHTLY ROTATE THE CAGE TO OBTAIN BETTER ALIGNMENT. WHEN THE NEXT X-RAY WAS TAKEN, IT WAS NOTICED THAT THE CAGE HAD FRACTURED DOWN THE MIDDLE. THE CAGE WAS LEFT IN AS IS. THERE ARE NO REPORTS OF ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7479030 ↗MalfunctionJul 10, 2017Fracture; Break; Fracture
IT WAS REPORTED THAT; CAGE BROKE UPON INSERTION TO THE DISC SPACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6699423 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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