VariAx 656314SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327070682), received between Nov 2, 2020 and Sep 4, 2024 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2024Biocompatibility; Biocompatibility

  THE FOLLOWING EMAIL WAS RECEIVED FROM A PATIENT: "I HAD SURGERY FOR A BROKEN WRIST ON (B)(6) LAST YEAR. I HAD AN ALLERGIC REACTION TO IT AND WOULD NOW LIKE TO HAVE IT TESTED TO FIND OUT EXACTLY WHAT I AM ALLERGIC TO. THE DERMATOLOGIST ASKED ME TO REQUEST AN 'INGREDIENT LIST' SO THAT THEY COULD KNOW WHICH SAMPLES TO USE FOR TESTING. THE ALLERGY WAS DISCOVERED ON 7/11/2023 THE PLATE AND SCREWS WERE REMOVED."

  Patient problems: Foreign Body Reaction

  MAUDE report 20140419 ↗
• InjuryJun 20, 2024Biocompatibility; Biocompatibility

  PATIENT FROM BELGIUM REPORTED THAT HE HAD SURGERY FOR A BROKEN WRIST. HE HAD AN ALLERGIC REACTION TO IT. HE WOULD LIKE TO KNOW WHICH MATERIAL CAUSE ALLERGY.

  Patient problems: Foreign Body Reaction

  MAUDE report 19578409 ↗
• MalfunctionMar 2, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THE T8 LOCKING SCREW WAS USED IN VARIAX FOOT SYSTEM IMPLANTING CASE (ORIF). BECAUSE THE SCREW FAILED TO LOCK WITH THE PLATE, THE SCREW WAS REPLACED WITH ANOTHER ONE (SAME SIZE SCREW)."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16470249 ↗
• MalfunctionDec 28, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE SURGEON COULD NOT GET THE LOCKING SCREW TO LOCK IN THE PLATE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060272 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE." ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR." SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023834 ↗
• MalfunctionDec 16, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "WHEN SCREWING IN A 2.7 DR SCREW, IT DID NOT BLOCK AND COULD BE TURNED. REPLACEMENT WAS AVAILABLE.". ADDITIONAL INFORMATION: "YES, IT HAS BEEN PRE-DRILLED. THE BONE QUALITY WAS VERY POOR.". SURGICAL DELAY OF 2 MINUTES NOT LONGER. NO OTHER CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11020437 ↗
• MalfunctionNov 2, 2020Positioning Failure; Positioning Failure

  AS REPORTED, "LOCKING SCREW DID NOT LOCK; THE SCREW WAS IDLING IN THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10774954 ↗