VariAx 40-20904Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04546540567437), received between Apr 4, 2018 and Jan 5, 2021 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 5, 2021Fracture; Fracture

  AS REPORTED: "THE FIRST SURGERY WAS PERFORMED ON (B)(6) 2020. AT THIS TIME, THE SOFT TISSUE WAS IN POOR CONDITION, AND THE PROCEDURE WAS COMPLETED WITH ONLY THE DISTAL ANTEROLATERAL PLATE OF THE AXSOS TIBIA, AND THEN THE VARIAX FIBULA WAS APPLIED ON (B)(6). AFTER 4 WEEKS OF UNLOADING, WE STARTED TO APPLY WEIGHT, AND AT 6TH WEEK WE STARTED FULL WEIGHTING, AND AT 7TH WEEK THE PATIENT FELT UNCOMFORTABLE. THE REVISION WAS MADE ON (B)(6). ONLY AXSOS AND ASNIS WERE REMOVED, AND VARIAX WAS NOT COMPLETELY BROKEN, SO IT WAS LEFT AS IT WAS. SINCE THE CONDITION OF THE SOFT TISSUE WAS STILL POOR, THE OPERATION WAS COMPLETED WITH VAC AFTER WEARING EXTERNAL FIXATION."

  Patient problems: Discomfort; Failure of Implant

  MAUDE report 11121143 ↗
• InjuryAug 27, 2020Fracture; Fracture

  IT WAS REPORTED: REP WAS CONTACTED BY SURGEON AND TOLD THAT THE PATIENT HAS A BROKEN PLATE ON HER RIGHT FIBULA. ON (B)(6) 2020, THE PATIENT SENT AN EMAIL REPORTING THE FOLLOWING: "I HAD ANKLE SURGERY FOR AN INTERNAL FIXATION ON (B)(6) ¿ON (B)(6) I WAS FULLY HEALED AND CLEARED TO WALK WITHOUT BOOT OR SCOOTER. (B)(6) MY ANKLE WAS SWOLLEN AND BURNING SO I WENT IN TO SEE MY SURGEON AND X-RAYS SHOWED THAT MY TITANIUM PLATE MADE BY STRYKER SNAPPED, RE-BROKE MY BONE AND SEVERED MY SURAL NERVE. I HAVE EMERGENCY SURGERY THIS FRIDAY (B)(6) TO REPAIR MY BONE, NERVE, REMOVE THE BROKEN PLATE, AND INSTALL A NEW PLATE". THE REP CONFIRMED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s); Burning Sensation; Failure of Implant; Implant Pain; Injury; Nerve Damage; Pain; Swelling; Swelling/ Edema

  MAUDE report 10462438 ↗
• InjuryMay 13, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINANT CALLED ON BEHALF OF PATIENT, STATING PATIENT HAD STRYKER SCREWS AND NAILS USED IN THEIR BROKEN ANKLE IN (B)(6) 2018. SINCE THIS DATE, PATIENT HAS BEEN HAVING ALLERGIC REACTIONS AND IT HAS NOT YET BEEN CONFIRMED WHAT IS THE CAUSE.

  Patient problems: Reaction

  MAUDE report 8605923 ↗
• MalfunctionApr 4, 2018Mechanics Altered

  IT WAS REPORTED THAT THE 4 DISTAL HOLES ("CLOVER SHAPED") OF THE SMALL FIBULAR PLATE DID NOT HAVE LOCKING MECHANISMS, ALLOWING SCREWS TO PASS CLEAN THROUGH THE PLATE. A SECOND PLATE WAS IMMEDIATELY AVAILABLE IN THE O.R. AND WAS USED WITH NO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7397444 ↗