VariAx 57-15391Recalls & reported problems
Stryker GmbH · 2.3 M VARIAX HAND LOCK 3-D 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154496754), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.
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
- Fracture1
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.
MalfunctionMar 26, 2019Break; Fracture; Fracture
IT WAS REPORTED THAT DURING THE OPERATION, THE PLATE BROKE AND DID NOT CAUSE ANY HARM TO THE PATIENT. DURING THE OPERATION, THE DOCTOR REPLACED THE PLATE TO COMPLETE THE OPERATION. THERE WAS NO SURGICAL DELAY, AND NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8453844 ↗
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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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