Tritanium PL 48954126Recalls & reported problems
Stryker Corporation · Posterior Lumbar Cage · Class 2 · Implant
All models of Tritanium PL (45)
Data updated Oct 18, 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 07613327117998), received between Jun 28, 2016 and Aug 25, 2023 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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 18, 2026.
Most reported problems
Device problems
- Break1
- Fracture1
- Migration1
Patient problems
- Device Embedded In Tissue or Plaque1
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 25, 2023Migration; Migration
A COMPANY REPRESENTATIVE REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY TO ADDRESS A POST-OPERATIVE TRITANIUM POSTERIOR LUMBAR CAGE MIGRATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17625028 ↗MalfunctionJun 28, 2016Break; Fracture; Fracture
IT WAS REPORTED THAT THE DOCTOR WAS INSERTING A CAGE INTO A DISC SPACE USING A ROTATE AND TURN TECHNIQUE UTILIZING A CUSTOM INSERTER WHEN THE GRAFT BROKE. HE WAS UNDER BILATERAL SCREW DISTRACTION AT THE TIME AND HAD SHAVED THE DISC SPACE TO THE CORRESPONDING CAGE HEIGHT. THE DOCTOR LEFT THE BROKEN SEGMENT IN THE SPACE AND BACK FILLED WITH BONE.
Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient
MAUDE report 5756193 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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