VariAx 54-25384SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04546540578716), received between May 15, 2023 and May 15, 2023 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN 2018, THE CLAIMANT HAD AN ORIF AND WAS IMPLANTED WITH UNKNOWN PINS AND A PLATE, AROUND (B)(6) 2021/ (B)(6) 2022, SHE FELT SOME DISCOMFORT/IRRITATION AND SOUGHT MEDICAL CARE. THE REVISION WAS SCHEDULED FOR JUNE 2022 TO REMOVE THE IMPLANTED DEVICES. DURING THE SURGERY, THE SURGEON DISCOVERED THAT HE DID NOT HAVE THE CORRECT INSTRUMENTS TO REMOVE THE HARDWARE. THE HOSPITAL SPENT SOME TIME TRYING TO FIND A SUITABLE TO ASSIST IN THE REMOVAL, BUT COULD NOT LOCATE A SUITABLE SCREWDRIVER. HOWEVER, ONE SCREW WAS ABLE TO BE REMOVED THROUGH CAREFUL USE OF A SMALLER SCREWDRIVER HEAD. SINCE THE FAILED SURGERY, THE PATIENT HAS BEEN LEFT WITH A RAISED RED RASH ON HER WRIST, AND IS IN MORE PAIN THAN BEFORE THE FAILED SURGERY. ADDITIONALLY, THIS IS AFFECTING HER WRIST MOVEMENT MORE THAT BEFORE THE SURGERY.

  Patient problems: Implant Pain; Loss of Range of Motion; Skin Inflammation/ Irritation

  MAUDE report 16930705 ↗