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Tritanium PL 48955166Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327118148), received between Mar 9, 2018 and Mar 9, 2018 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 9, 2018Fracture

    IT WAS REPORTED THAT A CAGE WAS IMPLANTED DURING L4-5 TLIF PROCEDURE ON (B)(6) 2016. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO INTER-OPERATIVE COMPLICATIONS. UPON REGULAR FOLLOW UP WITH THE PATIENT AND REVIEW OF POST OPERATIVE CT SCAN, IT WAS NOTICED THAT WHILST THE PATIENT HAD FUSED AND HAD NO POST OPERATIVE COMPLICATIONS/SYMPTOMS, THE IMPLANTED CAGE HAD SEVERAL POINTS OF FRACTURE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7328821 ↗

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Sources and updates

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