AXSOS 627486SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327082203), received between Feb 9, 2023 and Feb 9, 2023 — classified as 1 injury.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2023Break; Fracture; Break; Fracture

  AS REPORTED: "PLATE FRACTURE DUE TO PROLONGED HEALING. THE FIRST SURGERY (OSTEOSYNTHESIS FOR RIGHT DISTAL TIBIA) WAS PERFORMED ON (B)(6) 2022. ALTHOUGH THE ACTUAL DATE OF OCCURRENCE IS UNKNOWN, SKIN NECROSIS WAS FOUND AFTER THE SURGERY. NECROSIS GRADUALLY SPREAD TO THE SURROUNDING AREA AND REQUIRED SKIN GRAFTING. AFTER THAT, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 AS THE IMPLANTED PLATE WAS BROKEN. WHOLE PLATE WAS REMOVED, EXTERNAL FIXATION WAS PERFORMED, DEFECT SITE WAS FILLED WITH CEMENT, IN WHICH ANTIBIOTIC WAS MIXED, AND THE REVISION SURGERY WAS COMPLETED. THE OPERATOR TOLD THAT HE DID NOT KNOW WHEN THE INFECTION OCCURRED OR WHETHER THE PATIENT WAS FOLLOWING THE PERMITTED RANGE OF POST-TREATMENT."

  Patient problems: Failure of Implant; Necrosis; Nonunion/Delayed-union Bone Fracture

  MAUDE report 16335434 ↗