VariAx 656328Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327068733), received between Feb 3, 2022 and Feb 3, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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 3, 2022Break; Break

  AS REPORTED: "PATIENT INDICATED THAT THIS WAS THE SECOND SURGERY SHE IS HAVING WITH A STRYKER PRODUCT TO REVISE A STRYKER SCREW THAT WAS PUT IN PLACE BUT THE SCREW "STARTED COMING OUT" AFTER A FEW MONTHS. THE SCREW WAS REMOVED AND 2 NEW SCREWS AND A PLATE WERE PUT IN. A COUPLE MONTHS LATER THESE CRACKED AND CAUSED THE PLATE TO SHIFT WHICH LEFT THE PATIENT IN A LOT OF PAIN. THE SURGEON WAS ABLE TO REMOVE A PART OF THE SCREWS BUT PORTIONS OF THE SCREWS WERE TOO DEEPLY EMBEDDED IN THE PATIENT FOOT AND COULD NOT BE REMOVED. SHE MENTIONED THAT SHE HAS NOT BEEN ABLE TO PUT A SHOE ON IN OVER A YEAR AND A HALF AND HAS NOT BEEN VERY ACTIVE AS A RESULT OF THESE SURGERIES. SHE ALSO MENTIONED THAT HER SURGEON TOLD HER THAT HE HAD REPORTED THIS INCIDENT TO STRYKER. PATIENT ALSO MENTIONED THAT THEY HAD A BUNIONECTOMY IN THIS FOOT AS WELL. SHE WANTS TO CONSULT WITH "SOMEONE" BEFORE DECIDING IF THE SCREWS IN HER POSSESSION CAN BE RETURNED TO STRYKER FOR EVALUATION. THE SCREWS WERE PLACED IN MY FOOT IN (B)(6) 2020 THAT WERE MANUFACTURED BY STRYKER. ON A FOLLOW UP APPOINTMENT MY FOOT WAS STILL SWOLLEN AND I WAS IN A LOT OF PAIN. THE X-RAYS SHOWED THE SCREW HAD BROKE AFTER THEY WERE IN FOR ABOUT 8 WE

  Patient problems: Failure of Implant; Implant Pain; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema

  MAUDE report 13446400 ↗