VARIAX 657418Recalls & reported problems
Stryker GmbH · Bone Screw · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327073850), received between May 16, 2023 and May 16, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (2 reports).
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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Discomfort2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.
Patient problems: Discomfort
MAUDE report 16937828 ↗InjuryMay 16, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.
Patient problems: Discomfort
MAUDE report 16937650 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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