VariAx 656322SRecalls & reported problems
Stryker GmbH · Locking Screw, Fully Threaded,T8 · 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327070729), received between Dec 2, 2020 and Oct 28, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Positioning Failure” (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.
Reports received per month
Most reported problems
Device problems
- Positioning Failure2
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 28, 2025Positioning Failure; Positioning Failure
AS REPORTED: "VARIAX 2 DR CASE DURING DISTAL SCREW INSERTION, A 22MM LOCKING SCREW WAS INSERTED INTO THE SECOND HOLE FROM THE RADIAL SIDE. HOWEVER, IT FAILED TO LOCK. AN ATTEMPT WAS MADE TO REMOVE IT, BUT THE SCREW SPUN FREELY WITHIN THE SCREW HOLE AND COULD NOT BE REMOVED. AS IT COULD NOT BE REMOVED, THE SURGERY WAS COMPLETED WHILE THE UNLOCKED SCREW WAS LEFT IN PLACE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23405625 ↗MalfunctionDec 2, 2020Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent
AS REPORTED: "VARIAX2 DID NOT LOCK. THE SCREW HEAD WAS CRUSHED EVEN THOUGH THE DRILL GUIDE FITS IN THE PLATE SCREW HOLE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10931521 ↗
Other Screw, fixation, bone devices
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- 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.
How reports and recalls are matched · Editorial policy · Report an error on this page