VariAx 656314Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327068672), received between Jul 31, 2019 and Sep 25, 2025 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "IT WAS REPORTED THAT THE LOCKING SCREW WOULD NOT LOCK FIRMLY INTO THE LOCKING HOLE, AND THE SCREW WOULD JUST SPIN BOTH CLOCKWISE AND COUNTERCLOCKWISE. THE SURGEON COULDN'T REMOVE THE SCREW AND WITH ONLY ONE OTHER GOOD SCREW IN THE PROXIMAL SHAFT OF THE PLATE ABOVE HIS OSTEOTOMY, THE SURGEON HAD TO REDO THE CONSTRUCT WITH A LONGER PLATE. UPON PUTTING ON THE NEW PLATE (SAME VERSION OF PLATE BUT LONGER), THE SURGEON HAD THE SAME SCENARIO. UPON PUTTING ON THE PLATE USING THE IDENTICAL DRILL HOLES IN THE DISTAL END OF PLATE HAD HIS 3RD SCREW IN THE RADIAL STYLOID HOLE SPIN IN BOTH DIRECTIONS. THE LOCKING SCREW SPUN AGAIN AND COULDN'T BE REVERSED OUT OF THE PLATE. AT THIS POINT, THE SURGEON WAS REPORTEDLY FRUSTRATED AND HAD TO REMOVE THE PLATE AND SCREWS AND DECIDED TO CHANGE CONSTRUCTS USING ANOTHER VENDOR'S PLATE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT DEVICE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23144776 ↗
• MalfunctionNov 21, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "THE SCREWS DIDN'T LOCK INTO THE PLATE BUT ROTATED AROUND. THERE WAS ONE SCREW LEFT IN THE PLATE (IN THE PATIENT) WHICH COULD NOT BE REMOVED BUT ALSO DID NOT HOLD AS IT SHOULD. FURTHERMORE, TWO SCREWS WERE REMOVED AND WORKING LOCK SCREWS WERE PUT IN THEIR PLACE."

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745652 ↗
• MalfunctionNov 21, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "THE SCREWS DIDN'T LOCK INTO THE PLATE BUT ROTATED AROUND. THERE WAS ONE SCREW LEFT IN THE PLATE (IN THE PATIENT) WHICH COULD NOT BE REMOVED BUT ALSO DID NOT HOLD AS IT SHOULD. FURTHERMORE, TWO SCREWS WERE REMOVED AND WORKING LOCK SCREWS WERE PUT IN THEIR PLACE."

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20745611 ↗
• MalfunctionFeb 23, 2021Positioning Failure; Positioning Failure

  "IT WAS REPORTED THAT DURING A RIGHT DISTAL RADIUS PLATE IMPLANTATION, SCREWS WOULD NOT LOCK INTO SEVERAL OF THE DISTAL LOCKING HOLES OF THE PLATE. OVERALL, 14 SCREWS WERE WASTED. PLATE WAS SUCCESSFULLY IMPLANTED WITH A SURGICAL DELAY OF APPROXIMATELY 1 HOUR."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11369600 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9549273 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT MIDFOOT OPEN REDUCTION + INTERNAL FIXATION + LISFRANC STABILISATION. METALOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 9549209 ↗
• MalfunctionAug 13, 2019Difficult to Remove

  AS REPORTED: "VARIAX SCREWS LOCKED INTO THE PLATE AND WOULD NOT COME OUT" AND "NEEDED TO COMPLETELY REMOVE OUR PRODUCT AND PUT A DIFFERENT PRODUCT IN".

  Patient problems: Failure of Implant

  MAUDE report 8889995 ↗
• MalfunctionJul 31, 2019Difficult to Insert; Difficult to Insert; Defective Device

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT DISTAL RADIUS, AFTER PRE-DRILLING HOLES, THE FIRST LOCKING SCREW WAS PLACED AND WOULD NOT LOCK. THE SCREW JUST KEPT SPINNING IN THE PLATE. A SECOND SCREW WAS USED IN THE SAME HOLE AND LOCKED AS INTENDED. THIS SAME EXPERIENCE (FIRST SCREW NOT LOCKING, SECOND SCREW LOCKING) HAPPENED ON ADDITIONAL HOLES. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE ONE MINUTE DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848104 ↗
• MalfunctionJul 31, 2019Difficult to Insert; Difficult to Insert; Positioning Problem

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT DISTAL RADIUS, AFTER PRE-DRILLING HOLES, THE FIRST LOCKING SCREW WAS PLACED AND WOULD NOT LOCK. THE SCREW JUST KEPT SPINNING IN THE PLATE. A SECOND SCREW WAS USED IN THE SAME HOLE AND LOCKED AS INTENDED. THIS SAME EXPERIENCE (FIRST SCREW NOT LOCKING, SECOND SCREW LOCKING) HAPPENED ON ADDITIONAL HOLES. SURGERY WAS COMPLETED SUCCESSFULLY WITH AN APPROXIMATE ONE MINUTE DELAY AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8848095 ↗