OMEGA 597404SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154687428), received between Jan 21, 2020 and Jan 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJan 21, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  AS REPORTED: "THE OMEGA 3 SYSTEM WAS CHOSEN TO PROVIDE FIXATION OF AN INTERTROCHANTERIC FRACTURE ON A MALE TRAUMA PATIENT OF UNKNOWN AGE. THE OMEGA 135° GUIDE WAS USED TO INSERT THE OMEGA GUIDE PIN. OMEGA REAMER AND OMEGA TAP WERE USED BEFORE INSERTION OF LAG SCREW. AN OMEGA 3 LAG SCREW (95MM) WAS IMPLANTED OVER THE OMEGA GUIDE PIN. THE SURGEON DECIDED TO EXCHANGE IT FOR A LONGER LAG SCREW. THE REAR PART (SCREW/ DRIVER INTERFACE) OF THE 95MM LAG SCREW WAS VISUALLY DEFORMED AFTER EXTRACTION. AN OMEGA 3 LAG SCREW (105MM) WAS THEN INSERTED OVER THE GUIDE WIRE. DURING INSERTION, THE DISTAL (REAR) PART OF THE SCREW BEGAN TO DEFORM (AT THE SCREW/ DRIVER INTERFACE). THE DEFORMATION WAS VISUALIZED BY THE SURGEON. THE SURGEON ATTEMPTED TO INSTALL THE OMEGA 3 STABILIZATION PLATE ONTO THE LAG SCREW WITHOUT SUCCESS. THE LAG SCREW SCREWDRIVER WAS NOT ABLE TO REMOVE THE DAMAGED LAG SCREW. A CONICAL EXTRACTOR WAS USED TO SUCCESSFULLY REMOVE THE LAG SCREW. A NEW OMEGA 3 LAG SCREW (100MM) WAS THEN INSERTED OVER THE GUIDE WIRE. THE OMEGA STABILIZATION PLATE DID NOT FIT THE BONE TO THE SURGEON'S LIKING AND WAS REPLACED WITH AN OMEGA SHORT BARREL HIP PLATE 135°, 2 HOLE. X (4.5 X 40MM) SCREWS WERE INSE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9614101 ↗