VARIAX 40-20806Recalls & reported problems
Stryker GmbH · Straight Plate · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613252221975), received between Apr 13, 2020 and Apr 13, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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
- Break1
Patient problems
- Failure of Implant1
- Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 13, 2020Break; Break
AS REPORTED IN THE MAUDE DATABASE BY THE USER FACILITY (REPORT # (B)(4)): "PATIENT BROUGHT BACK TO OPERATING ROOM APPROXIMATELY ONE MONTH AFTER IMPLANT FOR ORIF RIGHT FOREARM FOR FAILED HARDWARE. THE SIX HOLE PLATE BROKE. THE PATIENT STATED THIS HAPPENED AFTER HE DID ONE PUSH UP. INITIAL SURGERY WAS UNEVENTFUL AND UNCOMPLICATED."
Patient problems: Failure of Implant; Injury
MAUDE report 9952850 ↗
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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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