VARIAX 657322SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327086966), received between Feb 10, 2020 and Dec 22, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387221 ↗
• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387218 ↗
• MalfunctionDec 22, 2023Material Fragmentation; Material Fragmentation

  AS REPORTED: "THREADED PIECES OF METAL APPEARED WHEN TIGHTENING A SCREW TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18387216 ↗
• MalfunctionNov 9, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THERE WERE THREE SCREWS THAT DID NOT LOCK, AND EACH TIME THE SURGEON HAD THEM REPLACED WITH SCREWS OF THE SAME SIZE OR 2 MM SHORTER. THE REPLACED SCREWS LOCKED WITHOUT ANY PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12777517 ↗
• MalfunctionOct 5, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT AT THE TIME OF VARIAX ELBOW OPERATION, THE LOCKING SCREW WAS INSERTED, BUT IT WAS NOT LOCKED. IT WAS DIFFICULT TO REMOVE AND SPENT EXTRA OPERATING TIME. THE SURGEON WAS ABLE TO REMOVE IT AND REPLACE IT WITH A LOCKING SCREW OF A DIFFERENT LENGTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12577127 ↗
• MalfunctionJan 5, 2021Positioning Failure; Difficult to Insert; Positioning Failure; Difficult to Insert

  AS REPORTED: "THE LOCKING SCREW COULD NOT BE COMPLETELY FASTENED. THE DOCTOR TRIED TO TURN IT WITH A SCREWDRIVER MANY TIMES, BUT I COULDN'T TURN THE SCREW ON THE WAY. DOCTOR'S VIEW: THE PATIENT'S BONES WERE STIFF AND THE SCREW COULD NOT ADVANCE. THE TIP OF THE SCREWDRIVER HAS COME OFF THE SCREW HEAD MANY TIMES. IT WOULD BE NICE TO HAVE A SCREW THAT CAN BE INSERTED EVEN IN PATIENTS WITH HARD BONES. I WANT THE TIP OF THE SCREWDRIVER TO BE SHAPED SO THAT IT DOES NOT COME OFF THE SCREW HEAD."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121220 ↗
• MalfunctionFeb 10, 2020Migration; Migration

  AS REPORTED: "IN 2006 MAYO PLATE WAS USED FOR NONUNION FRACTURE OF THE DISTAL HUMERUS. ON (B)(6) 2019, MAYO PLATE WAS REMOVED, AND MEDIAL AND LATERAL VARIAX ELBOW PLATE WAS IMPLANTED. TWO WEEKS AFTER REVISION SURGERY, BACK-OUT HAPPENED. (1 PROXIMAL LOCKING SCREW, 2 PROXIMAL CORTICAL SCREW, MOST DISTAL LOCKING SCREW OF LATERAL PLATE)". NO ADDITIONAL SURGERY IS PLANNED.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 9690090 ↗