VARIAX 628007SRecalls & 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 04546540686862), received between Nov 23, 2020 and Apr 29, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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
- Device Dislodged or Dislocated1
- Migration1
- Separation Problem1
Patient problems
- Failure of Implant1
- Impaired Healing1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryApr 29, 2022Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration
IT WAS REPORTED THAT THERE WAS SCREW LOOSENING AND POOR FIXATION WAS DISCOVERED. THEREFORE, ALL THE IMPLANTS WERE EXTRACTED.
Patient problems: Insufficient Information
MAUDE report 14251329 ↗InjuryNov 23, 2020Separation Problem; Separation Problem
AS REPORTED: "A (B)(6)-YEAR-OLD FEMALE PT UNDERWENT THE CLAVICLE JOINT SURGERY (LEFT) ON (B)(6) 2020. AFTER THE OPERATION, THE PLATE MOVED AND THE SCREW CAME OFF THE PLATE, AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020."
Patient problems: Failure of Implant; Impaired Healing
MAUDE report 10884971 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
- PRECICE® Plating System LP4.5-PLF40Nuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls0 reports
- 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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