VariAx 657126Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327069587), received between Dec 19, 2023 and Dec 19, 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 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.

• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD SURGERY ON (B)(6) 2018 TO INSERT A CLAVICLE PLATE AND SCREWS. PATIENT WENT BACK 2-DAYS POST-OP BECAUSE HE WAS EXPERIENCING A LOT OF PAIN. RECEIVED A CALL FROM ANESTHESIOLOGIST TO FOLLOW UP, PATIENT MENTIONED PAIN IN HIS JAW AND EAR. MAINTAINS THAT THERE MIGHT HAVE BEEN DAMAGE TO HIS THROAT WHEN REMOVING THE INTUBATION TUBE. WENT TO SEE ORTHOPEDIC DOCTOR FOR FOLLOW UP A WEEK LATER FOR SUTURE REMOVAL AND WHEN BANDAGES WERE REMOVED IT WAS NOTICED THAT IT DID NOT LOOK NORMAL. PATIENT HAD HARDWARE AND (B)(4) SCREWS INSERTED AND NOW HAS A BUMP STICKING OUT IN HIS CLAVICLE AND HAS BEEN HAVING PROBLEM EVER SINCE. HE IS EXPERIENCING PAIN AND LIMITED RANGE OF MOTION. CANNOT REALLY USE HIS LEFT ARM AND IS EXPERIENCING HIP PAIN. WHEN IN HOT WEATHER HE NEEDS TO COVER UP THE IMPLANT BECAUSE IT GETS HOT AND IT HURTS WHEN THE WEATHER IS COLD. HE CLAIMS THAT THE SURGERY IS BOTCHED. HARDWARE HAS NOT BEEN REMOVED AT THIS MOMENT.

  Patient problems: Deformity/ Disfigurement; Implant Pain; Loss of Range of Motion

  MAUDE report 18357105 ↗