Tritanium PL 48950086Recalls & reported problems
Stryker Corporation · Posterior Lumbar Cage · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327117349), received between Mar 1, 2018 and Apr 22, 2025 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Migration” (3 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
- Migration3
- Malposition of Device1
- Positioning Failure1
- Unintended Movement1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Injury1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2025Migration; Migration
IT WAS REPORTED THAT A TRITANIUM PL CAGE MIGRATED APPROXIMATELY ONE MONTH POST-OPERATIVELY. THE PATIENT EXPERIENCED NO SYMPTOMS AND WILL NOT BE REVISED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21887194 ↗InjuryJul 28, 2021Positioning Failure; Positioning Failure
IT WAS REPORTED THAT DURING PLACEMENT OF A TRITANIUM PL CAGE INTRA-OPERATIVELY, THE POSITIONING OF THE IMPLANT WAS NOT OPTIMAL. THE IMPLANT "PULLED OUT TO THE VENTRAL SIDE". TO REMOVE THE MISPOSITIONED CAGE, THE PATIENT WAS OPERATED ON LATERALLY. THE EVENT RESULTED IN A 60 MINUTE SURGICAL DELAY FOR THE ADDITIONAL SURGERY REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12239868 ↗InjuryJun 30, 2021Migration; Migration
IT WAS REPORTED THAT A RIGHT SIDE TRITANIUM PL CAGE AT L4/5 MIGRATED APPROXIMATELY 1 MONTH POST-OPERATIVELY. REVISION SURGERY WAS PERFORMED WHERE THE IMPLANT WAS REMOVED AND REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12094189 ↗InjuryMar 1, 2018Migration; Malposition of Device; Unintended Movement; Migration
IT WAS REPORTED THAT A PATIENT UNDERWENT L5/S1 POSTERIOR LUMBAR INTERBODY FUSION (PLIF) SURGERY IN OCTOBER 2017, WHICH WAS COMPLETED WITHOUT ISSUE. UPON FOLLOW UP, THE CAGE WAS REPORTED TO HAVE BACKED OUT. ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION SURGERY. THE CAGE WAS PUT INTO PROPER POSITION AND COMPRESSION WAS ADDED WITH A SCREW AND ROD.
Patient problems: Injury
MAUDE report 7306672 ↗
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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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