VariAx 53-27216ERecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613154913992), received between Sep 25, 2020 and Oct 27, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2020Positioning Failure; Fracture; Material Twisted/Bent; Positioning Failure; Fracture; Material Twisted/Bent

  AS REPORTED: "BY TIGHTENING ONE OF THE SCREWS, THIS GIVES UP WHAT THE SPECIALIST DOESN'T LIKE. / WHEN TAKING INTRAOPERATIVE X-RAY, TWO SCREWS MUST BE REMOVED TO RESET THEM, THE DOCTOR EXPRESSES THAT THE HEAD IS ALREADY ROLLED AND ARE ADDITIONALLY TORICIDED." ADDITIONAL INFORMATION: "1. WHEN ONE OF THE SCREWS (1ST SCREW) WAS BEING TIGHTENED IT LOST ITS HEAD, WHAT THE SPECIALIST DISLIKE. 2. WHEN TAKING INTRA-OPERATIVE RX, TWO SCREWS (2 ND AND 3 RD SCREWS )MUST BE REMOVED TO BE RE-ARRANGED ;WHEN REMOVING , THE DR EXPRESSED THAT ONE SCREW LOST ITS HEAD, IN ADDITION BOTH SCREWS WERE DISTORTED." "THERE WAS NOT HARD BONE" "OTHER SCREWS WERE USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741635 ↗
• MalfunctionOct 27, 2020Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED: "BY TIGHTENING ONE OF THE SCREWS, THIS GIVES UP WHAT THE SPECIALIST DOESN'T LIKE. / WHEN TAKING INTRAOPERATIVE X-RAY, TWO SCREWS MUST BE REMOVED TO RESET THEM, THE DOCTOR EXPRESSES THAT THE HEAD IS ALREADY ROLLED AND ARE ADDITIONALLY TORICIDED." ADDITIONAL INFORMATION: "1. WHEN ONE OF THE SCREWS (1ST SCREW) WAS BEING TIGHTENED IT LOST ITS HEAD, WHAT THE SPECIALIST DISLIKE. 2. WHEN TAKING INTRA-OPERATIVE RX, TWO SCREWS (2 ND AND 3 RD SCREWS )MUST BE REMOVED TO BE RE-ARRANGED ;WHEN REMOVING , THE DR EXPRESSED THAT ONE SCREW LOST ITS HEAD, IN ADDITION BOTH SCREWS WERE DISTORTED." "THERE WAS NOT HARD BONE" "OTHER SCREWS WERE USED TO COMPLETE THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741604 ↗
• MalfunctionSep 25, 2020Positioning Failure; Positioning Failure

  AS REPORTED: "BY TIGHTENING ONE OF THE SCREWS, THIS GIVES UP WHAT THE SPECIALIST DOESN'T LIKE. / WHEN TAKING INTRAOPERATIVE X-RAY, TWO SCREWS MUST BE REMOVED TO RESET THEM, THE DOCTOR EXPRESSES THAT THE HEAD IS ALREADY ROLLED AND ARE ADDITIONALLY TORICIDED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10589321 ↗