VARIAX 657310SRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327086799), received between Jul 22, 2020 and Feb 19, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionFeb 19, 2025Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW ON THE VARIAX FIBULA PLATE FAILED TO LOCK. AFTER OPENING ANOTHER SCREW, THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21417486 ↗
• MalfunctionJul 17, 2024Positioning Failure; Positioning Failure

  AS REPORTED: "LOCKING SCREW DID NOT LOCK." 7/4/2024 - ADDITIONAL INFORMATION RECEIVED. 3 SCREWS WERE SUCCESSFULLY IMPLANTED. LOCKING BAD SCREW IS NOT PUT IN, AND IT IS FINISHED AS IT IS. THE SURGEON IS RELATIVELY SATISFIED (BECAUSE IT IS USED IN CONJUNCTION WITH A TENSION BAND).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19767452 ↗
• MalfunctionMar 21, 2023Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  IT WAS REPORTED: "THE LOCKING SCREW DID NOT LOCK TO THE PLATE. A THIN METAL PIECE WAS FOUND DURING THE SCREW INSERTION. THE SCREW WAS REPLACED AND THE NEW SCREW WAS ABLE TO LOCK TO THE PLATE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587936 ↗
• MalfunctionMar 20, 2023Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK TO THE PLATE. THE SCREW AND THE PLATE WERE REPLACED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16577564 ↗
• MalfunctionNov 16, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK TO THE PLATE AFTER DRILLING WITH 2.6MM DRILL. ANOTHER LOT NUMBER SCREW WITH THE SAME SIZE LOCKED AGAINST THE SAME HOLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804089 ↗
• MalfunctionJun 28, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE LOCKING SCREW DID NOT LOCK TO THE PLATE. SPARE SCREW WAS ABLE TO LOCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14840540 ↗
• MalfunctionJan 17, 2022Positioning Failure; Positioning Failure

  AS REPORTED: "THE SUBJECT SCREW DID NOT LOCK TO THE FIBULA PLATE. THE SURGEON EXCHANGED IT TO A NEW ONE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266548 ↗
• MalfunctionJan 4, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT INTRAOPERATIVELY, THE LOCKING DID NOT LOCK, SO IT WAS REPLACED WITH A NEW SCREW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158084 ↗
• MalfunctionFeb 24, 2021Positioning Failure; Positioning Failure

  IT WAS REPORTED: "DURING THE INITIAL ORIF PROCEDURE FOR FIBULA (RIGHT SIDE), WHEN THE SURGEON ATTEMPTED TO INSERT THE 10MM LOCKING SCREW, IT DIDN'T FEEL LIKE IT WAS SPINNING OR TIGHTENING. THE REPORTING SR CONFIRMED THAT ANGLE OF THE DRILLING WAS LESS THAN 15 DEGREE, AND TRIED TO DRILL IT AGAIN. BUT IT DID NOT LOCK. THEREAFTER, WHEN THE SURGEON EXCHANGED WITH A NEW SCREW, IT LOCKED WITHOUT PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376332 ↗
• MalfunctionJul 22, 2020Positioning Failure; Material Fragmentation; Positioning Failure; Material Fragmentation

  IT WAS REPORTED: WHEN THE LOCKING SCREW WAS INSERTED INTO THE PLATE, THE SCREW THREAD WAS SCRAPED AND IT COULD NOT BE LOCKED. COLLECT THE SCREW AND DEBRIS. THE SURGEON INSERTED A NEW SCREW AND FINISHED THE OPERATION SUCCESSFULLY.

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

  MAUDE report 10311168 ↗