VARIAX 628205Recalls & reported problems
Stryker GmbH · Superior Lateral Plate · 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
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252442288), received between May 2, 2017 and Oct 16, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Device Dislodged or Dislocated1
Patient problems
- Failure of Implant1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE VARIAX CLAVICLE PLATE DID NOT SUCCEED IN FIXING THE FRACTURE. IT LOOKS AS IF THE SCREWS (BONE AND LOCKING SCREWS) DISLOCATED FROM THE PLATE.
Patient problems: Failure of Implant
MAUDE report 10688279 ↗MalfunctionMay 2, 2017Crack
IT WAS REPORT BY THE PHARMACIST, THAT WHEN MODELING A VARIAX CLAVICLE PLATE USING THE INSTRUMENTATION FROM THE ANCILLARY, THE SURGEON NOTICED A CRACK IN THE PLATE NEAR THE DRILLING HOLE. HE USED ANOTHER PLATE AND BEND IT WITHOUT ANY ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6539070 ↗
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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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