AXSOS 661044Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613252579878), received between Sep 21, 2018 and Oct 24, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 8002696 ↗
• InjurySep 21, 2018Migration or Expulsion of Device

  THE PATIENT WAS TREATED WITH A AXSOS PHL PLATE ON (B)(6) 2018. THE PATIENT COMPLAINED OF PAIN DURING HER FOLLOW-UP VISIT ON (B)(6) 2018. SCREWS OF THE PLATE HAD EMIGRATED. THE PATIENT HAD TO BE OPERATED AGAIN.

  Patient problems: Pain

  MAUDE report 7899327 ↗