VARIAX 40-20808SRecalls & 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 04546540667816), received between Jul 12, 2019 and Jul 12, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Appropriate Device Problem Term/Code Not Available1
- Fracture1
Patient problems
- No Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 12, 2019Fracture; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE PATIENT WAS UNDERGOING ORIF SURGERY WITH VARIAX FIBULA PLATE FOR FRACTURE OF THE ULNA AT (B)(6) 2019. AFTER THAT, THE PLATE WAS BROKEN AND REVISION SURGERY WAS DONE AT (B)(6) 2019. THE PATIENT HAD MENTAL ILLNESS AND THE SURGEON GUESSED THAT SHE HIT THE SURGICAL AREA AGAINST THE WALL MANY TIMES AND BROKE IT.
Patient problems: No Information
MAUDE report 8784647 ↗
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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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