VARIAX 628516SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327085525), received between Jun 4, 2019 and Sep 30, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Device” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "STIMULATION OF SOFT TISSUE DUE TO LOCKING SCREW BACKOUT. THE LOCKING SCREW WAS REMOVED." 09/06/2025 - ADDITIONAL INFORMATION RECEIVED: "THE SCREW AT THE MOST DISTAL END OF THE HOOK PLATE WAS ALSO LOOSE, BUT THAT WAS COMPLETELY LOCKED WHEN IT WAS RE-TIGHTENED, SO IT WAS RE-TIGHTENED. THE BACKED-OUT SCREW CAUSED IRRITATION, AND THE SKIN ON THE CLAVICLE SURFACE WAS RED AND SWOLLEN."

  Patient problems: Erythema; Skin Inflammation/ Irritation; Swelling/ Edema

  MAUDE report 23184987 ↗
• MalfunctionJun 4, 2019Defective Device

  IT WAS REPORTED THAT VARIAX CLAVICLE SURGERY WAS PERFORMED ON 5/7/2019. WHEN THE SURGEON TRIED TO LOCK THE LOCKING SCREW TO THE SECOND HOLE FROM THE DISTAL END OF THE PLATE, IT DID NOT LOCK. THE SURGEON DECIDED TO LEAVE THE SCREW IN A STATE THAT IS NOT LOCKED TO THE PLATE. THE PROCEDURE WAS OTHERWISE COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY OR ADVERSE CONSEQUENCES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8668134 ↗