VARIAX 628205SRecalls & reported problems
Stryker GmbH · Superior Lateral 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 04546540687074), received between Feb 9, 2024 and Feb 9, 2024 — 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.
Reports received per month
Most reported problems
Device problems
- Break1
- Fracture1
Patient problems
- Failure of Implant1
- Implant Pain1
- Nonunion/Delayed-union Bone Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 9, 2024Break; Fracture; Break; Fracture
IT WAS REPORTED THAT A VARIAX CLAVICLE PLATE WAS INSERTED ON (B)(6) 2023. THE PATIENT WAS FOLLOWED UP WITH AFTER THE PROCEDURE AND IT WAS NOTED THAT THE PROGRESS OF BONE FUSION WAS POOR. THE SURGEON AT THE TIME SUGGESTED REPLACING THE PLATE WITH A BONE GRAFT, HOWEVER THIS WAS NOT FOLLOWED THROUGH. ON (B)(6) 2023 THE PATIENT FELT PAIN AND VISITED A DIFFERENT HOSPITAL WHERE IT WAS DISCOVERED THAT THE PLATE WAS BROKEN. ON (B)(6) 2023 THE PATIENT UNDERWENT A REVISION SURGERY TO REPLACE THE BROKEN PLATE.
Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture
MAUDE report 18677067 ↗
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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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