VariAx 657016SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327071283), received between Jul 28, 2020 and Nov 24, 2020 — 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

Recent adverse event reports

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

• MalfunctionNov 24, 2020Positioning Failure; Device Dislodged or Dislocated; Positioning Failure; Device Dislodged or Dislocated

  AS REPORTED; "WHEN ORIF PROCEDURE (RIGHT, FOOT JOINT) WAS PERFORMED AS THE INITIAL OPERATION, THE HEAD POPPED OUT FROM VARIAX FOOT PLATE AND DID NOT LOCK."

  Patient problems: Insufficient Information

  MAUDE report 10891537 ↗
• MalfunctionJul 28, 2020Positioning Failure; Positioning Failure

  IT WAS REPORTED: FRACTURE OF THE DISTAL CLAVICLE. VARIAX CLAVICLE PLATE SUPERIOR 3 LATERAL HOLES WAS USED. A SCREW WAS INSERTED ON THE LATERAL SIDE, BUT LOCKING WAS NOT POSSIBLE. IT IS POSSIBLE THAT IT WAS INSERTED BY DRILLING AT AN EXCESSIVE ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10334398 ↗