VARIAX 657322Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327086959), received between Aug 7, 2020 and May 16, 2023 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 16937718 ↗
• InjuryMay 16, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING A VARIAX CLAVICULA PLATE REMOVAL, WHILST REMOVING THE SCREWS AND PLATE THE SURGEON NOTICED SOME METAL PARTICLES IN THE WOUND. ADDITIONAL INFORMATION: THE REASON FOR THE REMOVAL OF THE PLATE WAS THE DISCOMFORT IT CAUSED. THERE WAS NO DEBRIS LEFT IN THE PATIENT.

  Patient problems: Discomfort

  MAUDE report 16937622 ↗
• MalfunctionMar 12, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THE FOLLOWING ISSUE: "THE MATERIALOVIGILANCE DECLARATION HAS NOT YET BEEN MADE BY THE SURGEON, IT SEEMS THAT THERE WAS A PROBLEM WITH THE SCREW THREAD AND THAT THERE WAS A SPARK WITH A VISIBLE FLAME WHEN THE DRILL WAS INSERTED." UPDATE - 2/21/2022: THE PROCEDURE COULD BE COMPLETED CORRECTLY BY OPENING THE CLAVICLE ANCILLARY TO RECOVER THE SCREW RACKS OF THE SAME SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13743337 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379710 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379612 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379610 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379608 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379523 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379516 ↗
• MalfunctionAug 7, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  AS REPORTED: "THE SURGEON TRIED TO FIX THE CALCANEUS MESH PLATE WITH 3.5 MM VARIAX2 LOCKING SCREWS DURING SURGERY. 7 SCREWS FROM THE MESH WERE NOT TIGHTENED, WENT LOOSE AND A SMALL CHIP CAME OFF THE THREAD OF SOME OF THEM. REPLACEMENTS WERE AVAILABLE TO COMPLETE THE MEDICAL PROCEDURE SUCCESSFULLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10379515 ↗