VariAx 656020Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327068375), received between Sep 19, 2018 and Jul 25, 2023 — classified as 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "FAILURE OF LOCKING SCREWS IN A DISTAL RADIUS PLATE. 9 SCREWS WERE USED IN TOTAL BUT ONLY 1 HAD A FAILURE TO LOCK INTO PLACE. THE SURGEON IS HOPEFUL THE FIXATION IS ADEQUATE EVEN WITHOUT THE ONE SCREW LOCKING PROPERLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393993 ↗
• 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 17377217 ↗
• 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 17376816 ↗
• MalfunctionAug 25, 2021Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  AS REPORTED: "THE SURGEONS WERE PERFORMING AN OPEN REDUCTION PROCEDURE OF THE RIGHT DISTAL RADIO WHICH THE DORSAL PART WAS SOMETHING COMMINUTE, A RIGHT EXTRACTOR PLATE IS PLACED. DISTAL RADIO 49MM REFERENCE 5425683 LOT 1000428950 THE OVAL HOLE OF THE BRANCH IS FIXED TO THE DISTAL PART OF THE PLATE WITH A CORTICAL SCREW OF 2.7X 16MM VERIFYING WITH X-RAYS AND THEN FIXING THE DISTAL PART USING THE 2.0MM LOCKING GUIDE HOLES WHICH DO NOT BLOCK, SEVERAL DRILLINGS ARE MADE IN DIFFERENT HOLES BUT THE SAME HAPPENED WITHOUT BLOCKING THE SCREWS, WHICH HAD BEEN USED 2.4MM X 18MM, 20MM, 22MM BLOCK T. AND THEN THE LAST BRANCH OF THE DISTAL HOLE IS FIXED PROXIMAL PART OF THE PLATE WITH A 2.7X14MM CORTICAL SCREWS, IT IS DECIDED TO REMOVE THE PLATE TO VERIFY THE DIRECTION OF THE HOLES AND THEIR LOCKING FUNCTION, SMART LOOK SYSTEM, BUT THEY DO NOT BLOCK THE ORIFICES AND THEY ARE MADE WITH A NEW SCREWS. THE SURGEON WAS ANGRY BY SUCH EVENT WHICH DECIDES NOT TO USE THE DISTAL RADIO SYSTEM WITH THE USED PLATE ANY MORE AND TO FIX THE H, DISTAL RADIO OF L APTE WITH KIRSCHNER NAILS 1.25 AND 1.1MM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12365806 ↗
• MalfunctionJan 7, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE DISTAL RADIUS VARIAX 2 SCREWS ARE FRAYING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9558911 ↗
• MalfunctionSep 19, 2018Mechanical Problem

  PRIMARY PROCEDURE, RIGHT DISTAL RADIUS. AS REPORTED: DR (B)(6) WAS USING A 2.4X20 VARIAX2 LOCKING SCREW AND WHEN DOING HIS FINAL TIGHTENING THE SCREW WOULD NOT LOCK. HE WAS ABLE TO KEEP THE SCREW IN PLACE BUT THE LOCKING MECHANISM WAS NOT FULLY UTILIZED. NEITHER THE PATIENT NOR THE OUTCOME OF THE SURGERY WAS AFFECTED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891488 ↗