VariAx 656414Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327068894), received between Jan 3, 2020 and Mar 25, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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.

• MalfunctionMar 25, 2026Fracture; Difficult to Remove

  THE CUSTOMER REPORTED THE FOLLOWING: "DURING WRIST OSTEOSYNTHESIS USING A PLATE, THE HEAD OF A CORTICAL SCREW BROKE. THIS INCIDENT MADE IT DIFFICULT TO REMOVE THE SCREW AND THEREFORE HAD AN IMPACT ON THE DURATION OF THE PROCEDURE. HOWEVER, IT WAS EVENTUALLY REMOVED. THE SCREW CAME FROM THE VARIAX WRIST ANCILLARY. AFTER SOME TIME, THE SURGEON SUCCESSFULLY REMOVED THE DEFECTIVE MATERIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24688558 ↗
• InjuryFeb 13, 2023Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH PAIN IN THE RIGHT FOOT AND IN THE IMPLANT. THE PATIENT HAD HARDWARE REMOVED DUE TO MECHANICAL FAILURE/MALFUNCTION OF FUSION( RIGHT FOOT). THE INITIAL DIAGNOSIS WAS PSEUDARTHROSIS AFTER FUSION OR ARTHRODESIS. THE PRE-OPERATIVE DIAGNOSIS WAS RIGHT HALLUX LIMITUS WITH NON-UNION. NON-UNION HALLUX INTERPHALANGEAL JOINT FUSION. THE PATIENT UNDERWENT REVISION RIGHT FIRST METATARSAL PHALANGEAL JOINT FUSION. RIGHT FOOT HARDWARE REMOVAL. RIGHT HALLUX ARTHROPLASTY. CALCANEAL BONE GRAFT HARVESTING.

  Patient problems: Implant Pain; Loss of Range of Motion; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16362682 ↗
• MalfunctionDec 20, 2021Break; Break

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "WHEN INSERTING THE SCREW INTO THE PLATE, THE SCREW HEAD BROKE OFF. REPLACEMENT WAS AVAILABLE. THE BROKEN SCREW IS STILL IN SITU, IT WAS LEFT AS IT DOES NOT INTERFERE." 3/12/2021 - ADDITIONAL INFORMATION RECEIVED: SCREW HEAD REMOVED AND DISCARDED, ONLY ONE SCREW DISTALLY FROM THE FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13049574 ↗
• 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 12365808 ↗
• MalfunctionNov 10, 2020Fracture; Fracture

  AS REPORTED: "DR. WAS TIGHTENING THE SCREW INTO THE PLATE BY HAND AND THE HEAD OF THE SCREW CLEANLY TWISTED OFF OF THE SHAFT" SURGICAL DELAY - 10 MINUTES.

  Patient problems: Foreign Body In Patient

  MAUDE report 10819588 ↗
• 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. METALLOSIS WAS OBSERVED DURING REMOVAL.

  Patient problems: Injury; Reaction

  MAUDE report 9549421 ↗