VARIAX 40-20806SRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540667793), received between Jun 4, 2018 and Feb 6, 2025 — classified as 1 injury, 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
- Mechanics Altered1
Patient problems
- Failure of Implant1
- No Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 6, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED: "A VARIAX FIBULA STRAIGHT PLATE USED IN THE ULNA BROKE OFF 3 WEEKS AFTER THE SURGERY. REVISION SURGERY IS PLANNED ON (B)(6) 2025".
Patient problems: Failure of Implant
MAUDE report 21329374 ↗MalfunctionJun 4, 2018Mechanics Altered
DURING VARIAX FIBULA SURGERY, THE LOCKING SCREW DID NOT LOCK IN THE MOST DISTAL HOLE. THE SCREW WAS ONCE REMOVED, REMOVAL AND CLEANING OF SOFT TISSUE WAS PERFORMED, BUT THE ISSUE WAS NOT RESOLVED. THE SURGEON EXCHANGED THE SCREW WITH ANOTHER SAME SIZE SCREW, BUT THE SCREW COULD NOT BE LOCKED. THEREFORE, RE-DRILLING WAS PERFORMED USING DRILL SLEEVE BUT THE ISSUE WAS NOT RESOLVED. ULTIMATELY, THE SURGERY WAS FINISHED WITH THE SCREW UNLOCKED AND LAG SCREW FIXATION WAS ADDED USING 3.5MM NON-LOCKING SCREW IN ORDER TO INCREASE FRACTURE STABILITY.
Patient problems: No Information
MAUDE report 7567057 ↗
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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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