VariAx 656312Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327068665), received between Feb 21, 2019 and Feb 23, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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.

• 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 11369635 ↗
• 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 11369602 ↗
• 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: Failure of Implant

  MAUDE report 8890001 ↗
• 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 8889988 ↗
• 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".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8889805 ↗
• MalfunctionJun 4, 2019Material Deformation; Scratched Material; Defective Device; Material Deformation; Scratched Material

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT RADIUS, THE LOCKING SCREW WOULD NOT LOCK INTO THE PLATE. WHEN SEATED, THE SCREW KEPT SPINNING. ANOTHER SCREW WAS USED TO SUCCESSFULLY COMPLETE THE SURGERY WITH AN APPROXIMATE ONE MINUTE DELAY. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8668538 ↗
• InjuryFeb 21, 2019Patient-Device Incompatibility

  ALLEGEDLY THE PATIENT UNDERWENT FOOT SURGERY IN (B)(6) 2018 WITH STRYKER COMPONENTS AND SUBSEQUENTLY HAD THE HARDWARE REMOVED IN (B)(6) 2018. PATIENT ALLEGES SHE HAD A REACTION TO THE MATERIAL COMPOSITIONS OF THESE SYSTEMS WHICH RESULTED IN ALLEGED INJURY OF COMPLEX REGIONAL PAIN SYNDROME (CRPS).

  Patient problems: Reaction

  MAUDE report 8359068 ↗