AXSOS 661050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579908), received between Feb 24, 2021 and Mar 26, 2021 — classified as 1 injury, 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2021Fracture; Fracture

  AS REPORTED: "SCREW BREAKAGE IN AXSOS 3 DISTAL MEDIAL PLATE DESCRIBED BY CUSTOMER AS COLD WELDING. PROXIMAL LOCKING SCREW MEASURED TOO LONG, WHEN GOING TO CHANGE THE SCREW OUT THE SCREW HEAD BROKE. THE LOCKING TOWER WAS USED CORRECTLY, THE TORQUE WRENCH WAS USED TO TIGHTEN THE SCREW INITIALLY. INITIAL REMOVAL WAS ATTEMPTED ON HAND SCREWDRIVER. A BROKEN SCREW REMOVAL SET WAS USED TO REMOVE THE BROKEN SCREW FROM THE LATERAL SIDE, TO DO THIS A BURR WAS USED TO REMOVE A PORTION OF A FIBULA PLATE WHICH HAD BEEN PLACED IN THE SAME OPERATION. 2 SCREW DRIVER SHAFTS WERE BROKEN IN THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577611 ↗
• InjuryFeb 24, 2021Fracture; Fracture

  AS REPORTED: "DR. USED THE ANKLE FUSION PLATE TO FUSE THE TIBIOTALAR JOINT. WE PUT IN 7 SCREWS (4.0 LOCKING QTY 4, 3.5 CORTEX SCREWS QTY 2, 6.5 CANNULATED SCREW QTY 1) INTO THE PLATE. THE PATIENT CAME BACK TO CLINIC TODAY 1/28 IN SOME PAIN AND DR. TOOK AND X-RAY AND WE DISCOVERED 3 SCREWS HAVE BROKEN AND THE PLATE IS SITTING OF THE BONE." ADDITIONAL INFORMATION: SCREWS BROKE SOMETIME BETWEEN 12/17-1/28. THE PATIENT CAME IN ON 1/28 WITH PAIN AND SWELLING OF HER ANKLE. WE DETERMINE THROUGH X-RAY THAT THE SCREWS FAILED. BEFORE SHE WAS WEIGHT BEARING AS TOLERATED AND NOW SHE IS IN A CAM BOOT. NO FURTHER ACTION HAS BEEN PLANNED AT THE MOMENT. HER ACTIVITY LEVEL IS LOW AND SHE IS DIABETIC. SHE HAS HAD PREVIOUS SURGERIES ON SAME FOOT 6 YEARS AGO. ORIF OR RIGHTY TRI MAL AND SYNDESMOTIC SCREWS AND THEN HARDWARE REMOVAL. HER DIABETES IS POORLY CONTROLLED A1C IS HIGH.

  Patient problems: Failure of Implant; Implant Pain; Swelling/ Edema

  MAUDE report 11376333 ↗