Tritanium PL 48953132Recalls & 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 07613327295832), received between Sep 17, 2019 and May 21, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Migration” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Migration2
- Appropriate Device Problem Term/Code Not Available1
- Migration or Expulsion of Device1
Patient problems
- No Known Impact Or Consequence To Patient1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 21, 2025Migration; Migration
IT WAS REPORTED THAT ONE TRITANIUM POSTERIOR LUMBAR CAGE BECAME JAMMED AND WAS SUBSEQUENTLY REMOVED FROM THE PATIENT INTRA-OPERATIVELY, AND THAT A SECOND TRITANIUM POSTERIOR LUMBAR CAGE MIGRATED INTRA-OPERATIVELY, "PARTIALLY ENTERED THE VERTEBRAL BODY", AND WAS ALSO REMOVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO REPORTED SURGICAL DELAY BY INSERTING A THIRD CAGE LATERAL FROM THE INITIAL APPROACH. THIS REPORT IS FOR THE CAGE THAT MIGRATED.
Patient problems: Unspecified Tissue Injury
MAUDE report 22063405 ↗MalfunctionSep 17, 2019Migration or Expulsion of Device; Appropriate Device Problem Term/Code Not Available; Migration; Migration
A PHYSICIAN REPORTED A POST-OPERATIVE MIGRATION OF A TRITANIUM PL CAGE PLACED AT S1. REVISION SURGERY IS NOT PLANNED AND THERE HAS BEEN NO ADVERSE CONSEQUENCE TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9079552 ↗
Other Intervertebral fusion device with bone graft, lumbar devices
- T-PAL 03.812.003Synthes GmbH · Intervertebral fusion device with bone graft, lumbar152 reports
- T-PAL 03.812.004Synthes GmbH · Intervertebral fusion device with bone graft, lumbar120 reports
- Catalyft PL Expandable Interbody System 6068073Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall66 reports
- Catalyft PL Expandable Interbody System 6069076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall51 reports
- Catalyft PL Expandable Interbody System 6068076Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall46 reports
- EIT TLIF Inserter TFT30101EIT Emerging Implant Technologies GmbH · Intervertebral Fusion Device With Bone Graft, Lumbar88 reports
- T-PAL 03.812.001Synthes GmbH · Intervertebral fusion device with bone graft, lumbar76 reports
- Catalyft PL Expandable Interbody System 6069096Medtronic Sofamor Danek, Inc. · Intervertebral fusion device with bone graft, lumbar1 recall25 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page