Tritanium PL 48951106Recalls & 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
- 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 07613327117585), received between Jan 3, 2018 and Oct 16, 2018 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Difficult to Remove1
- Material Protrusion/Extrusion1
- Migration1
- Migration or Expulsion of Device1
Patient problems
- Injury1
- No Known Impact Or Consequence To Patient1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2018Migration; Migration or Expulsion of Device; Migration
IT WAS REPORTED THAT THE CAGE MIGRATED AND RETRO PULSED INTO THE CANAL, PATIENT WAS DOING HEAVY LIFTING POSTOP. THE PATIENT WAS COMPLAINING OF PAIN AND UNDERWENT REVISION SURGERY.
Patient problems: Injury; Pain
MAUDE report 7970775 ↗MalfunctionJan 3, 2018Difficult to Remove; Device Dislodged or Dislocated; Material Protrusion/Extrusion; Device Dislodged or Dislocated
IT WAS REPORTED THAT; DURING PLIF SURGERY USING CAGE, ONE OF THE CAGES PROTRUDED TO THE ANTERIOR SIDE UPON FINAL IMPACTION. SINCE THE PROTRUDED CAGE WAS UNABLE TO BE REMOVED FROM POSTERIOR SIDE, REMOVAL SURGERY IS SCHEDULED IN THE NEAR FUTURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7160566 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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