Tritanium TL 48932010Recalls & reported problems
Stryker Corporation · Half Saddle Tamp · Class 1
All models of Tritanium TL (6)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327376098), received between Feb 20, 2019 and Feb 20, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unintended Movement” (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
- No Apparent Adverse Event1
- Unintended Movement1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 20, 2019Unintended Movement; No Apparent Adverse Event; No Apparent Adverse Event
IT WAS REPORTED THERE WAS NO ISSUE WITH THE TAMP WHICH WAS USED IN AN ATTEMPT TO ROTATE THE CAGE. THE CAGE CONTINUED TO MOVE FORWARD AND BECAME TOO ANTERIOR TO THE DESIRED POSITIONING.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 8354489 ↗
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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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