VARIAX 657450SRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327074277), received between Sep 2, 2020 and Jul 9, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (4 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.
Reports received per month
Most reported problems
Device problems
- Material Fragmentation4
- Unraveled Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 9, 2024Material Fragmentation; Unraveled Material; Material Fragmentation; Unraveled Material
THE SCREW HAS APPEARS TO LOOSE THREADS AND NOT PROPERLY SCREW INTO A ANKLE PLATE THAT REQUIRED REVISION OF JUST THE SCREW AND AN OVERALL 10 MINUTES DELAY TO SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19705293 ↗MalfunctionSep 2, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING THE CASE THE SCREW THREAD ON 3 SCREWS APPEARS TO HAVE STRIPPED OFF IN PLACES
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10485322 ↗MalfunctionSep 2, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING THE CASE THE SCREW THREAD ON 3 SCREWS APPEARS TO HAVE STRIPPED OFF IN PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10485321 ↗MalfunctionSep 2, 2020Material Fragmentation; Material Fragmentation
THE CUSTOMER REPORTED THAT DURING THE CASE THE SCREW THREAD ON 3 SCREWS APPEARS TO HAVE STRIPPED OFF IN PLACES.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10485319 ↗
Other PLATE, FIXATION, BONE devices
- Lapiplasty System 2 SK14Treace Medical Concepts, Inc. · Plate, Fixation, Bone260 reports
- PRECICE® Plating System LP4.5-PRF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls6 reports
- PRECICE® Plating System LP4.5-MLT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls5 reports
- PRECICE® Plating System LP4.5-PLF4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- PRECICE® Plating System LP4.5-MRT4BNuvasive Specialized Orthopedics, Inc. · Plate, Fixation, Bone3 recalls3 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page