AXSOS 607330Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613252578536), received between Aug 25, 2020 and Jul 21, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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.

• MalfunctionJul 21, 2021Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING ONE 4.0 X 30 MM CANCELLOUS SCREW FULL THREAD ON THE AXSOS 3 TIBIA PLATE, THE SCREW HEAD BROKE. THE BODY OF THE SCREW REMAINS IN PATIENT'S BODY. NO ADVERSE CONSEQUENCES TO THE PATIENT OR CLINICALLY SIGNIFICANT SURGICAL DELAY WERE REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202262 ↗
• MalfunctionAug 25, 2020Fracture; Fracture

  AS REPORTED: "THE HEADS BROKE OFF WHEN THE SCREWS WERE SCREWED IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10451921 ↗
• MalfunctionAug 25, 2020Fracture; Fracture

  AS REPORTED: "THE HEADS BROKE OFF WHEN THE SCREWS WERE SCREWED IN."

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10451920 ↗