OMEGA 704009Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613153054511), received between Aug 28, 2020 and Aug 26, 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.

• MalfunctionAug 26, 2021Fracture; Fracture

  IT WAS REPORTED "THE THREAD OF THE INNER PART BROKE OFF INTRAOPERATIVELY. REPLACEMENT WAS AVAILABLE. A SURGICAL DELAY OF 1 MINUTE WAS REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12369743 ↗
• MalfunctionMar 4, 2021Fracture; Fracture

  "THE CUSTOMER REPORTED THAT THE LAG SCREW ADAPTER BROKE WHILE THE SURGEON WAS INSERTING THE SCREW. THE LAG SCREW HAD TO BE REMOVED AND A NEW SCREW WAS INSERTED." UPDATE: THE CASE WAS COMPLETED BY OPENING ANOTHER SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11414010 ↗
• MalfunctionAug 28, 2020Fracture; Fracture

  AS REPORTED: "THE LAG SCREW ADAPTER BROKE OFF."

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

  MAUDE report 10467332 ↗