VARIAX 614636Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154969869), received between Feb 11, 2019 and Feb 11, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Slipped” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2019Device Slipped

  IT WAS BACK OUT THAT THE MOST DISTAL SCREW OF THE AT THE POSTOPERATIVE X - RAY. AS SURGEON'S COMMENT, IT IS NOT THAT THE ANGLE OF THE SCREW WAS OVERTURNED TOO MUCH BUT ONLY THAT ONE WAS NOT LOCKED. THE SCREW WAS REMOVED AND THE SCREW WAS REINSERTED AS REVISION SURGERY. ADDITIONAL INFORMATION: ¿THE ANGLE OF THE SCREW HAD NOT BEEN OVERTURNED TOO MUCH AND THE SCREW HAD BEEN LOCKED INITIALLY. BUT AT THE POSTOPERATIVE X-RAY, IT WAS FOUND OUT THAT THE ONLY DISTAL SCREW WAS NOT LOCKED.¿

  Patient problems: No Code Available

  MAUDE report 8329630 ↗