Tritanium PL 48950110Recalls & 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 07613327117370), received between May 29, 2018 and Jan 14, 2019 — 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Migration2
- Device Dislodged or Dislocated1
- Device Operates Differently Than Expected1
Patient problems
- Injury1
- No Code Available1
- 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.
InjuryJan 14, 2019Device Dislodged or Dislocated; Migration; Migration
SURGEON SENT PICTURE OF PATIENT WHO ORIGINALLY HAD A T11-PELVIS FUSION ON (B)(6) 2018. IMAGE SHOWS BOTH RODS HAD POPPED OUT OF THE PELVIC SCREWS AND THE CAGE AT L4-L5 HAD BACKED OUT. REQUIRED REVISION OF FUSION (SCREWS ADDED AT S1; AND RODS RE-SEATED AND REVISED IN PELVIC BOLTS), EXTRACTION OF CAGE, AND CLOSURE OF DURAL TEAR AT L4/L5.
Patient problems: Injury; No Code Available
MAUDE report 8243721 ↗MalfunctionMay 29, 2018Device Operates Differently Than Expected; Migration; Migration
IT WAS REPORTED THAT A CAGE HAD BACKED OUT POST OPERATIVELY. THIS WAS NOTICED BY THE SURGEON ON AN X-RAY. PATIENT IS ASYMPTOMATIC, NO REVISION IS SCHEDULED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7551302 ↗
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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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