VARIAX 657318Recalls & reported problems
Stryker GmbH · Locking Screw · 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 07613327086911), received between Apr 14, 2021 and Apr 14, 2021 — 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.
Most reported problems
Device problems
- Positioning Failure2
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.
MalfunctionApr 14, 2021Positioning Failure; Positioning Failure
AS REPORTED: "VARIAX 2 T10 LOCKING SCREWS WERE NOT ENGAGING WITH THE DISTAL CLUSTER HOLES IN THE ANATOMIC FIBULA PLATES. 4 SCREWS IN A ROW. IT HAPPENED WHILE TRYING TO LOCK THE SCREWS TO THE PLATE. PROLONGATION OF THE CASE DUE TO INSERTING, NOT ENGAGING, REMOVING, DRILLING AGAIN, MEASURING AGAIN AND IMPLANTING A SHORTER LOCKING SCREW TO ONLY HAVE IT NOT ENGAGE AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11668562 ↗MalfunctionApr 14, 2021Positioning Failure; Positioning Failure
AS REPORTED: "VARIAX 2 T10 LOCKING SCREWS WERE NOT ENGAGING WITH THE DISTAL CLUSTER HOLES IN THE ANATOMIC FIBULA PLATES. 4 SCREWS IN A ROW. IT HAPPENED WHILE TRYING TO LOCK THE SCREWS TO THE PLATE. PROLONGATION OF THE CASE DUE TO INSERTING, NOT ENGAGING, REMOVING, DRILLING AGAIN, MEASURING AGAIN AND IMPLANTING A SHORTER LOCKING SCREW TO ONLY HAVE IT NOT ENGAGE AGAIN."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11668458 ↗
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- 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.
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