VARIAX 657412SRecalls & reported problems
Stryker GmbH · Bone Screw · 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
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327073768), received between Mar 19, 2019 and May 3, 2022 — classified as 2 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.
Most reported problems
Device problems
- Device Dislodged or Dislocated2
- Flaked2
- Material Fragmentation2
- Migration2
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 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 14271460 ↗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 14251328 ↗MalfunctionMar 19, 2019Flaked; Material Fragmentation; Detachment of Device or Device Component; Flaked
WHILE DRIVING A BONE SCREW INTO A DISTAL FIBULA PLATE, METAL WIRES(CHIPS) CAME FROM THE SCREW. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8434674 ↗MalfunctionMar 19, 2019Flaked; Material Fragmentation; Flaked
WHILE DRIVING A BONE SCREW INTO A DISTAL FIBULA PLATE, METAL WIRES(CHIPS) CAME FROM THE SCREW. NO SURGICAL DELAY OR ADVERSE CONSEQUENCES WERE REPORTED. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8434671 ↗
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- PRECICE® Plating System LP4.5-DRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls1 report
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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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