Tritanium PL 48953112Recalls & reported problems
Stryker Corporation · Posterior Lumbar Cage · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327295825), received between Apr 8, 2019 and Mar 5, 2026 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Fracture1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Injury1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 5, 2026Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNSPECIFIED SURGICAL DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24519739 ↗InjuryApr 8, 2019Migration or Expulsion of Device; Migration; Migration
IT WAS REPORTED THAT THE PATIENT THAT WAS IN PAIN. UPON POST-OP X-RAY, IT WAS CONFIRMED THAT THE CAGE HAD MIGRATED. THE PATIENT UNDERWENT REVISION SURGERY TO REPLACE THE CAGE WITH LARGER SIZE CAGE.
Patient problems: Injury; Pain
MAUDE report 8492739 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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