VARIAX 657432Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327074048), received between Oct 9, 2020 and Jul 22, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Difficult to Setup or Prepare” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THE FOLLOWING: "I HAVE BEEN INFORMED OF AN INCIDENT THAT OCCURRED DURING THE INSTALLATION OF A VARIAX PLATE REF.(B)(4): A FRAGMENT OF PLATE DETACHED ITSELF IN THE FORM OF A THREAD DURING SCREWING, CAUSING A WOUND ON THE SURGEON'S RIGHT HAND. AN ACCIDENT DUE TO EXPOSURE TO BLOOD AND A WORK-RELATED ACCIDENT WERE REPORTED."

  Patient problems: Perforation

  MAUDE report 19792460 ↗
• MalfunctionJun 2, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  AS REPORTED: "A STRAIGHT PLATE OF THE VARIAX FOOT SYSTEM WAS REQUIRED FOR A REDUCTION OF THE DISTAL TIBIA AND AT THE TIME OF PLACING THE SCREWS TO FIX IT, THEY WENT THROUGH THE HOLES OF THE PLATE DISPLACING THE PLATE AND IT HAD TO BE REMOVED AND IT WAS NEEDED TO FIND ANOTHER WAY TO MAINTAIN THE REDUCTION INCREASING THE SURGICAL TIME."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17054713 ↗
• InjuryOct 9, 2020Fracture; Fracture

  AS REPORTED: "ORIGINAL CASE WAS FOR A BUNION DEFORMITY, WHERE A LAPIDUS PROCEDURE WAS PERFORMED (B)(6) 2019. DISSECTION, JOINT PREPARATION, AND FIXATION DURING THE CASE WENT FLAWLESS. NO CONCERNS ON DAY OF THE CASE. THE PATIENT PRESENTED 4-6 WEEKS OUT WITH POSSIBLE NON UNION. UPON THE NEXT XRAYS TAKEN, A NON UNION WAS SHOWN, AND A FEW SCREWS USED THROUGH THE PLATE WERE BROKEN FROM THE MOVEMENTS AND INSTABILITY CAUSED BY THE NON UNION AT THE FUSION SITE." DATE OF EXPLANT REPORTED: (B)(6) 2020.

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 10657367 ↗