AXSOS 661436Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252580393), received between Mar 29, 2019 and Feb 24, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 11376331 ↗
• MalfunctionApr 2, 2019Break

  IT WAS REPORTED THAT, DURING A PRIMARY PROCEDURE ON A RIGHT TIBIA, A DRILL BIT BROKE, AND A SCREW BROKE DURING IMPLANTATION. THE PROXIMAL TIBIA PLATE BECAME DAMAGED. THE SCREW WAS REMOVED. THE SURGERY WAS COMPLETED USING ANOTHER KIT. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 5-10 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8474896 ↗
• MalfunctionMar 29, 2019Break

  IT WAS REPORTED THAT, ON (B)(6) 2019, DR. WAS FIXING A DISTAL TIBIA FRACTURE. DURING THE IMPLANTING OF TWO DIFFERENT SCREWS, THE SCREWS SNAPPED AND BROKE IN HALF. ADDITIONALLY DURING DRILLING, THE TIP OF THE DRILL BIT BROKE IN THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO ADVERSE CONSEQUENCES OR SURGICAL DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8464240 ↗