NA 54-25442SRecalls & reported problems
Stryker GmbH · 2.7mm XXL Volar DR Plate, Narrow, RI. · Class 2 · Implant
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 04546540640932), received between Dec 1, 2018 and Dec 1, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem1
Patient problems
- 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.
MalfunctionDec 1, 2018Contamination /Decontamination Problem
WHEN THE BONE SCREW(2.7MM) WAS INSERTED INTO THE SCREW HOLE OF THE PLATE (54-25442S), THE SCRAPED PIECE WAS FELL. THE SCRAPED PIECE WAS REMOVED FROM THE PATIENT BODY AND THE SCREW AND PLATE WAS IMPLANTED. THE SURGEON WANT TO KNOW WHAT FOREIGN MATTER WAS SCRAPED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121807 ↗
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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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