VARIAX 628027Recalls & reported problems
Stryker GmbH · Superior Plate - Decreased Curvature · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252441953), received between Mar 25, 2019 and Aug 15, 2019 — classified as 2 injuries.
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
- Mechanical Problem1
- Physical Resistance/Sticking1
Patient problems
- Failure of Implant2
- Fall1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 15, 2019Break
IT WAS REPORTED THAT THE PATIENT'S RIGHT CLAVICLE WAS REVISED. PATIENT FELL OUT OF A CHAIR, BROKE THE EXISTING VARIAX PLATE, AND LOST REDUCTION. PATIENT WAS REVISED TO ANOTHER VARIAX PLATE.
Patient problems: Failure of Implant; Fall
MAUDE report 8898804 ↗InjuryMar 25, 2019Mechanical Problem; Physical Resistance/Sticking
VARIAX CLAVICLE DEVICE IMPLANTED ON (B)(6) 2019. REVISION SURGERY (SCHEDULED (B)(6) 2019) REQUIRED DUE TO POOR FIXATION.
Patient problems: Failure of Implant
MAUDE report 8448157 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
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- PRECICE® Plating System LP4.5-PRT42Nuvasive Specialized Orthopedics, Inc. · Plate, 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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