VARIAX 657420Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327073874), received between Nov 18, 2022 and May 16, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 16937623 ↗
• MalfunctionJan 30, 2023Positioning Problem; Positioning Problem

  AS REPORTED: "A MEDIAL COLUMN PLATE WAS USED FROM THE VARIAX SET, THE SURGEON DRILLED THE OBLONG HOLE USING THE COMPRESSION SIDE OF THE DRILL GUIDE, TO ACHIEVE COMPRESSION, WITH A 2.6MM DRILL BIT. HE PLACED A 3.5MM NL SCREW IN THE HOLE AND WHILE HE WAS TIGHTENING TO ACHIEVE COMPRESSION, THE SCREW FELL THROUGH THE PLATE. THE SURGEON BACKED OUT THE SCREW THAT HAD FALLEN THROUGH THE PLATE, AND THEN REPLACED SAME SCREW BACK IN THE PLATE. THIS CAUSED AROUND A TWO-MINUTE DELAY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16269488 ↗
• MalfunctionNov 18, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AS THE SCREW PROGRESSED, IT WOULD NOT ENGAGE THE LOCKING MECHANISM. IT WAS FURTHER REPORTED THAT IT SPUN FREELY LOSING ALL COMPRESSION ON THE BONE. A SURGICAL DELAY OF 45-MINUTES WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15825065 ↗