Tritanium PL 48954076Recalls & reported problems
Stryker Corporation · Posterior Lumbar Cage · Class 2 · Implant
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327117943), received between Jun 6, 2018 and Sep 27, 2024 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Fracture” (3 reports).
1 FDA recall record name this device's identifier.
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
Recalls naming this device
- Nov 28, 2018Terminated
The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
Z-0605-2019 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Fracture3
- Break1
- Migration1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE CAGE WAS REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO ADVERSE CONSEQUENCES TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20318264 ↗InjuryJun 30, 2021Migration; Migration
IT WAS REPORTED THAT FOLLOWING A FALL APPROXIMATELY 1 MONTH POST-OPERATIVELY, A PATIENT'S TRITANIUM PL CAGE AT L4-L5 MIGRATED FROM THE DISK SPACE. FUSION WAS NOT ACHIEVED. REVISION SURGERY WAS PERFORMED WHERE THE CAGE WAS EXPLANTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12094825 ↗MalfunctionMay 19, 2021Fracture; Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE FRACTURED INTRA-OPERATIVELY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11848176 ↗MalfunctionJun 6, 2018Break; Fracture; Fracture
IT IS REPORTED THAT THE CAGE WAS FOUND BROKEN DURING A FOLLOW UP VISIT. THE CAGE WAS FUSED AND NO REVISION SURGERY IS PLANNED. NO ADVERSE CONSEQUENCE TO THE PATIENT IS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7572736 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.