VARIAX 657416Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327073829), received between Jan 10, 2023 and May 17, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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.
Reports received per month
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth2
- Material Fragmentation1
Patient problems
- Failure of Implant2
- Malunion of Bone2
- Discomfort1
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "FRACTURE OF THE LEFT CLAVICLE, DISPLACED ANGULATED WITH SIGNS OF MALUNION DUE TO SEPARATION OF THE PLATE FROM THE DISTAL END WITH THREE COMPLETELY LOOSE SCREWS, THIS INFORMATION WAS DESCRIBED BY THE SPECIALIST DURING THE SURGICAL FINDING. THE FAILING MATERIAL IS REMOVED AND REPLACED WITH A NEW PLATE AND PLACEMENT OF NEW AND MORE SCREWS ON THE PATIENT."
Patient problems: Failure of Implant; Malunion of Bone
MAUDE report 19341633 ↗InjuryMay 17, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
AS REPORTED: "FRACTURE OF THE LEFT CLAVICLE, DISPLACED ANGULATED WITH SIGNS OF MALUNION DUE TO SEPARATION OF THE PLATE FROM THE DISTAL END WITH THREE COMPLETELY LOOSE SCREWS, THIS INFORMATION WAS DESCRIBED BY THE SPECIALIST DURING THE SURGICAL FINDING. THE FAILING MATERIAL IS REMOVED AND REPLACED WITH A NEW PLATE AND PLACEMENT OF NEW AND MORE SCREWS ON THE PATIENT."
Patient problems: Failure of Implant; Malunion of Bone
MAUDE report 19341630 ↗InjuryJan 10, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. HE REPORTED THE CASE TO THE HEAD NURSE AND GAVE HER ALL IMPLANTS (PLATES + SCREWS).
Patient problems: Discomfort; Foreign Body In Patient
MAUDE report 16131215 ↗
Other Screw, fixation, bone devices
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- 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.
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