VariAx 657128Recalls & reported problems
Stryker GmbH · Bone Screw, Fully Threaded,T10 · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327069594), received between May 3, 2019 and May 3, 2019 — classified as 1 malfunction.
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
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2019Break
IT WAS REPORTED THROUGH A MEDWATCH (MW5085445) "A FEMALE WHO IS STATUS POST SPANNING EXTERNAL FIXATION FOR AN OPEN INTRA-ARTICULAR LEFT DISTAL TIBIA FRACTURE. SHE PRESENTS BACK TO THE OPERATING ROOM TODAY. AT THIS POINT WE TURNED OUT ATTENTION TO THE MEDIAL WOUND AND PACKED THE LATERAL WOUND OPEN. THE MEDIAL WOUND WAS REOPENED AND EXTENDED PROXIMALLY APPROX. 6 CM FOR A LONG COMMINUTED MEDIAL SPIKE. WITH THE SKIN OPEN, THE SUBCUTANEOUS FAT WAS DIVIDED LONGITUDINALLY AND THE POSTERIOR MEDIAL CORNER OF THE TIBIA WAS IDENTIFIED AND EXPOSED. THE FRACTURE WAS NOTED TO BE COMMINUTED ON THE MEDIAL SIDE WITH 2 MAIN FRACTURE FRAGMENTS, ONE WITH A LARGE ANTEROMEDIAL BUTTERFLY FRAGMENT AND A LARGE POSTERIOR CENTRAL FRAGMENT. THEY WERE MOBILIZED CURETTED, IMPAIRED AND THE REDUCED WITH 2 LOBSTER CLAW WITH K-WIRES. AT THIS POINT A 10-HOLE 2.7 MM PLATE FROM STRYKER WAS THE FASHION ON THE POSTERIOR MEDIAL CORTEX OF THE TIBIA, AND WAS FIXED PROXIMALLY WITH 3 SCREWS AND NO SCREWS IN THE DISTAL FRAGMENT TO NOT BLOCK OUR REDUCTION AND MANIPULATION ON THE LATERAL SIDE. OUR REDUCTION SHOWED OUR ALIGNMENT IN THE SAGITTAL AND CORONAL PLANE TO BE EXCELLENT ON THE MEDIAL SIDE. WE TURNED OUR ATTENTION BACK TO
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8579695 ↗
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 STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-200Nuvasive 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 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