VariAx 657116Recalls & 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
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327069549), received between Jul 29, 2019 and May 17, 2024 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Loosening of Implant Not Related to Bone-Ingrowth1
- Material Fragmentation1
Patient problems
- Failure of Implant1
- Malunion of Bone1
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
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 19340222 ↗MalfunctionNov 15, 2022Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THERE WAS METAL DEBRIS AFTER REMOVING THE PLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15796087 ↗InjuryJul 29, 2019Detachment of Device or Device Component
CLAVICLE REVISION CASE; REVISION WAS DUE TO PREVIOUS PLATE AND SCREWS PULLING OUT FROM BONE. SURGEON BELIEVES THIS WAS DUE TO THE PATIENT 'LIFTING WEIGHTS' IN THE GYM EARLIER THAN ADVISED AFTER SURGERY. REVISION CASE WENT ACCORDING TO PLAN WITH NO ISSUES ENCOUNTERED. PATIENT WAS COMPLIANT AND IN A SLING FOR 2 MONTHS. PATIENT IS ALSO A HEAVY SMOKER AND WENT BACK TO WORK AS A CONCRETER AFTER 2 MONTHS POST CASE.
Patient problems: No Code Available
MAUDE report 8839440 ↗
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.
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