AXSOS 661430Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613252580362), received between May 1, 2018 and Feb 24, 2021 — classified as 2 injuries, 2 malfunctions.

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 4 most recent of 4 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 11376327 ↗
• InjuryOct 24, 2018Appropriate Device Problem Term/Code Not Available

  THE HOSPITAL REPORTED THE FOLLOWING EVENT : "DURING RADIOGRAPHIC INSPECTION AT 9 MONTHS OF OSTEOSYNTHESIS SHOWS A PSEUDOSEPTIC OSTEOARTHRITIS OF THE LEFT TIBIA WITH FRACTURE OF THE OSTEOSYNTHESIS PLATE (PLACED ON (B)(6) 2018 FOLLOWING AN OPEN FRACTURE IN THE LEFT LEG). PROVISIONAL MEASURES AND ACTIONS TAKEN: NEED FOR SURGICAL RESUMPTION ON (B)(6) 2018 WITH REMOVAL OF THE MATERIAL, SAMPLES, FIRST TIME MASK WITH SPACER IN CEMENT FIXATION BY EXTERNAL FIXATOR AND ANTIBIOTIC THERAPY. THE DEVICE HAS BEEN RETAINED FOR EXPERTISE. CLINICAL CONSEQUENCES NOTED: NEED FOR SURGICAL RESUMPTION AND SEPTIC PSEUDARTHROSIS."

  Patient problems: Bone Fracture(s)

  MAUDE report 8002691 ↗
• MalfunctionSep 10, 2018Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE HEADS OF TWO SCREWS TWISTED OFF DURING NORMAL USE. BOTH SCREWHEADS SNAPPED AT THE JUNCTURE OF THE SHAFT THREAD TRANSITION. AS THE SCREWS SNAPPED THEIR HEADS, ADDITIONAL SCREWS HAD TO BE ADDED TO THE PLATE IN ORDER TO COMPENSATE FOR THE LOSS OF FIXATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7861832 ↗
• MalfunctionMay 1, 2018Hole In Material; Malposition of Device

  WHILE TIGHTENING THE SCREW TO THE PLATE, THE SCREW HAS PASSED THOUGH THE OVAL HOLE ON THE PLATE. NOTICED ON X-RAY CHECK OF SCREW POSITION. EXTRA PROCEDURE TIME REQUIRED TO REMOVE AND REDUCE THE FRACTURE 45 MINS.

  Patient problems: No Information

  MAUDE report 7475052 ↗