Tritanium PL 48950076Recalls & 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 07613327117288), received between Jun 11, 2019 and Jul 15, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture2
- Break1
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.
MalfunctionJul 15, 2024Fracture; Fracture
A COMPANY REPRESENTATIVE REPORTED THAT A TRITANIUM PL CAGE FRACTURED APPROXIMATELY 3 MONTHS POST-OPERATIVELY. NO ADVERSE CONSEQUENCES WERE REPORTED. REVISION SURGERY HAS NOT BEEN PERFORMED NOR SCHEDULED AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19741998 ↗InjuryJun 11, 2019Fracture; Break; Fracture
PATIENT RECEIVED A PLIF OF L4/5 FOR NEUROLOGICAL SYMPTOMS SUCH AS LEG PAIN DUE TO LUMBAR SPINAL CANAL STENOSIS ON (B)(6) 2019. X-RAYS CONFIRMED THE CAGE FRACTURE IS LOCATED ANTERIORLY IN THE DISC SPACE. RELATION OF PATIENT'S PAIN AND BROKEN CAGE IS UNCLEAR. PATIENT PRESCRIBED MEDICINE FOR PAIN AND IS UNDER OBSERVATION.
Patient problems: Injury; Pain
MAUDE report 8687276 ↗
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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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