VariAx 656318Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327068696), received between Mar 8, 2019 and Sep 25, 2025 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (7 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 14 most recent of 14 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 23144777 ↗
• MalfunctionJul 24, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING SCREW DID NOT ENGAGE THE PLATE AS DESIGNED, SPINS WITHOUT LOCKING. ANGLE ADJUSTED AND STILL NO ¿GRAB¿ TO LOCK. THE SURGERY WAS COMPLETED BY GETTING ADEQUATE FIXATION WITH THE OTHER SCREWS. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17378477 ↗
• 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 11369644 ↗
• 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 11369642 ↗
• 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 11369637 ↗
• MalfunctionFeb 18, 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 11345321 ↗
• MalfunctionDec 22, 2020Positioning Failure; Positioning Failure

  AS REPORTED: 'NO BLOCKING WAS POSSIBLE THE PLATE HAD TO BE REMOVED. REPLACEMENT WAS AVAILABLE. SURGICAL DELAY OF 15MIN. NOT LONGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11060647 ↗
• MalfunctionOct 29, 2020Fracture; Fracture

  AS REPORTED: "IN THE ACT OF THE SURGEON BLOCKING THE SCREW ON THE PLATE, THE SCREW HEAD BROKE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10759490 ↗
• MalfunctionOct 22, 2020Fracture; Fracture

  IT WAS REPORTED "THAT DURING THE CASE TWO OF THE 2.7MM (8) CORTEX SCREW HEADS BROKE OFF AT THE HEAD ON TIGHTENING. IT WAS FURTHER REPORTED THAT THE SURGEON DID NOT USE ANY MORE FORCE THAN USUAL." SURGICAL DELAY: APPROXIMATELY 10 MIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10719781 ↗
• MalfunctionAug 13, 2019Difficult to Remove; Physical Resistance/Sticking; Difficult 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." ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889998 ↗
• MalfunctionAug 13, 2019Difficult to Remove; Physical Resistance/Sticking; Difficult 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." ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889809 ↗
• 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." ADDITIONALLY REPORTED: "THESE EACH LOCKED INTO THE PLATE BUT WERE SPINNING AS IF THEY WEREN¿T LOCKED. THE HEADS DID NOT STRIP BUT THE SURGEON WAS UNABLE TO BACK THE SCREW OUT FROM THE PLATE, AND HAD TO RIP THE ENTIRE CONSTRUCT OUT AS ONE. THIS WAS THE FIRST CASE WITH THIS PATIENT AND WAS NOT A REVISION SURGERY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889806 ↗
• 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: No Known Impact Or Consequence To Patient

  MAUDE report 8889522 ↗
• MalfunctionMar 8, 2019Defective Device

  IT WAS REPORTED THAT WHEN IMPLANTING A VARIAX 2 DISTAL RADIUS PLATE, THE LOCKING SCREW DID NOT LOCK INTO THE PLATE. ANOTHER SCREW WAS USED AND LOCKED INTO THE PLATE SUCCESSFULLY. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 2 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8406062 ↗