Tritanium PL 48954106Recalls & 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327117974), received between Mar 12, 2018 and Jun 5, 2020 — classified as 2 injuries.
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.
Most reported problems
Device problems
- Fracture2
- Break1
Patient problems
- Injury2
- 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.
InjuryJun 5, 2020Fracture; Fracture
IT WAS REPORTED THAT A TRITANIUM PL CAGE AND A XIA CT POLYAXIAL CORTICAL SCREW, IMPLANTED AT L5-S1, FRACTURED POST-OPERATIVELY. FUSION WAS NOT ACHIEVED. REVISION SURGERY WILL OCCUR TO REPLACE DEVICES. THIS REPORT CAPTURES THE CAGE.
Patient problems: Injury; No Clinical Signs, Symptoms or Conditions
MAUDE report 10125234 ↗InjuryMar 12, 2018Break; Fracture
IT WAS REPORTED THAT THE CAGE WAS DISCOVERED FRACTURED AT THE LEVEL OF L4/L5 IN AN X-RAY, POST OPERATIVELY. THERE WAS NO FUSION IN THE CAGE. INITIAL SURGERY TOOK PLACE ON (B)(6) 2016, AFTER WHICH THE PATIENT EXPERIENCED PAIN AND VISITED THE DOCTOR¿S OFFICE. IN ADDITION TO THE CAGE, THE PATIENT WAS IMPLANTED WITH ANOTHER DEVICE MANUFACTURER'S SCREWS AND BONE GRAFT. THE SCREWS WERE REPORTED BROKEN AND IMAGING INDICATED THERE IS AN INFLAMMATION RESPONSE TO THE OTHER DEVICE MANUFACTURER'S BONE GRAFT AROUND THE CAGE.UPON FOLLOW-UP, IT WAS REPORTED THAT THE PATIENT WILL UNDERGO REVISION SURGERY.ADDITIONAL INFORMATION (B)(6) 2018: REVISION SURGERY TOOK PLACE ON (B)(6) 2018. A NEW CAGE WAS IMPLANTED ALONG WITH SUPPLEMENTAL FIXATION SYSTEM. THE PATIENT IS DOING WELL AFTER THE REVISION SURGERY. THE ORIGINAL SUPPLEMENTAL FIXATION SYSTEM WAS EXPLANTED AND RETAINED BY THE PATIENT. 2 SCREWS AND 1 ROD WERE REPORTED BROKEN.
Patient problems: Injury; Pain
MAUDE report 7331353 ↗
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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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