VariAx 40-15011Recalls & reported problems
Stryker GmbH · CURVED PLATE · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613154627783), received between May 22, 2019 and Apr 15, 2026 — classified as 3 injuries, 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
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Detachment of Device or Device Component1
- Fracture1
Patient problems
- Impaired Healing1
- Injury1
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Reaction1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryApr 15, 2026Fracture
AS REPORTED "THE VARIAX 2 PLATE WAS IMPLANTED ON (B)(6) 2025 AND FRACTURED OUTSIDE A MEDICAL FACILITY. SUBSEQUENT REMOVAL AND REOSTEOSYNTHESIS TOOK PLACE ON (B)(6) 2026."
Patient problems: Insufficient Information
MAUDE report 24887035 ↗MalfunctionFeb 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED: "THE VARIAX 2 LOCKING SCREWS T10 2.7 HAVE NOT LOCKED IN THE PLATE. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: THE FIRST LOOK HERE SHOULD BE ON THE PLATE, THE DOCTOR TOLD ME. THE SCREW SEEMS TO BE ¿WELDED¿ WITH THE PLATE. I HAVE NO NUMBERS FOR THE SCREW BUT THEY ARE BOTH ON THE POST WAY TO STRYKER FOR EVALUATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11333314 ↗InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
VARIAX FOOT PLATE METALOSIS NOTICED UPON REMOVAL ON 3-DEC-19 BY SURGEON.IMPLANTED ON 5-JUN-19. REMOVAL NOT FOR NON-UNION, JUST REMOVAL OF METALWARE.
Patient problems: Injury; Reaction
MAUDE report 9549256 ↗InjuryMay 22, 2019Break
PATIENT'S HUSBAND CALLED STATING HIS WIFE HAD A LEFT FOOT SURGERY DONE ON (B)(6) 2017. HUSBAND STATED MRIS SHOWED THE PLATE BROKEN IN HALF, THE PLATE WAS REMOVED ON (B)(6) 2018. DURING REMOVAL OF PLATE THE SURGEON NOTICED THE BONE WAS HEALING INCORRECTLY, THEREFORE PATIENT WAS NOT IMPLANTED WITH ANOTHER PLATE.
Patient problems: Impaired Healing
MAUDE report 8631411 ↗
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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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