VARIAX 657338SRecalls & reported problems
Stryker GmbH · Locking Screw · Class 2 · Implant
All models of VARIAX (345)
Data updated Oct 16, 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 07613327087154), received between May 17, 2023 and May 17, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Fragmentation” (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.
Most reported problems
Device problems
- Material Fragmentation2
Patient problems
- Insufficient Information2
- 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.
MalfunctionMay 17, 2023Material Fragmentation; Material Fragmentation
AS REPORTED: "WHEN INSERTING THE 3.5MM LOCKING SCREW INTO THE LOCKING HOLE OF THE PLATE, A METALLIC THREAD WAS FOUND. THE SAME PROBLEM OCCURRED AGAIN WITH A NEW SCREW. THEN THE THIRD SCREW WAS INSERTED AFTER TAPPING AND IT WAS LOCKED WITH NO PROBLEM."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16945693 ↗MalfunctionMay 17, 2023Material Fragmentation; Material Fragmentation
AS REPORTED: "WHEN INSERTING THE 3.5MM LOCKING SCREW INTO THE LOCKING HOLE OF THE PLATE, A METALLIC THREAD WAS FOUND. THE SAME PROBLEM OCCURRED AGAIN WITH A NEW SCREW. THEN THE THIRD SCREW WAS INSERTED AFTER TAPPING AND IT WAS LOCKED WITH NO PROBLEM."
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16945598 ↗
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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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