VARIAX 628525SRecalls & reported problems
Stryker GmbH · Hook Plate · 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 07613327085426), received between Nov 27, 2019 and Nov 27, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
- Difficult or Delayed Positioning1
- Migration1
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.
MalfunctionNov 27, 2019Difficult or Delayed Positioning; Migration; Difficult or Delayed Positioning; Migration
IT WAS REPORTED: DURING VARIAX CLAVICLE SURGERY, THE LOCKING SCREW DID NOT LOCK TO THE SECOND HOLE FROM THE DISTAL OF THE PLATE. THE SURGEON EXCHANGED THE SCREW TO THE NEW ONE, BUT THE SITUATION WAS NOT CHANGED. THE SURGEON INSERTED THE SECOND SCREW AS IT IS TO THE HOLE AND FINISHED THE SURGERY. THE SCREW IS AVAILABLE AND WILL BE RETURNED FIRST. FEW MONTHS LATER, THE PLATE WILL BE RETURNED AFTER THE EXTRACTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9387600 ↗
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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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