Tritanium PL 48950102Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327295023), received between Jul 10, 2018 and Dec 16, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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.
Reports received per month
Most reported problems
Device problems
- Migration3
- Migration or Expulsion of Device1
- Unintended Movement1
Patient problems
- Injury2
- Failure of Implant1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 16, 2025Migration; Migration
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23824527 ↗InjuryFeb 25, 2019Migration or Expulsion of Device; Migration; Migration
IT WAS REPORTED THAT THE CAGE WAS MIGRATED FROM ORIGINAL POSITION POST-OPERATIVELY. THE PATIENT WAS IN PAIN AND UNDERWENT REVISION SURGERY.
Patient problems: Injury; Pain
MAUDE report 8366937 ↗InjuryJul 10, 2018Unintended Movement; Migration; Migration
IT WAS REPORTED THAT AFTER AN L2/L3 TIIF SURGERY, THE CAGE BACKED OUT OF THE IMPLANTED SPACE. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE CAGE.
Patient problems: Failure of Implant; Injury
MAUDE report 7674375 ↗
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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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