OMEGA 3362-5-090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327093025), received between Mar 28, 2019 and Dec 12, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 other recall cover devices cleared under the same FDA submission (K955306); they may or may not involve this specific model.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE OMEGA LAG SCREW BROKE UPON INSERTION INTO THE PATIENT. THE BREAKAGE WAS OBSERVED DURING THE LAST HALF-TURN OF THE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 9458171 ↗
• MalfunctionJul 8, 2019Material Deformation; Break; Loose or Intermittent Connection; Material Deformation

  IT WAS REPORTED THAT AS THE LAG SCREW WAS BEING INSERTED, THE INTERFACE BETWEEN THE LAG SCREW AND THE INSERTER BECAME LOOSE. THIS PREVENTED THE SURGEON FROM COMPLETING THE INSERTION. UPON REMOVAL OF THE LAG SCREW, IT WAS NOTICED THAT THE LAG SCREW WAS DAMAGED AT THE DRIVING END. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 5-10 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8767256 ↗
• MalfunctionMar 28, 2019Deformation Due to Compressive Stress

  THE CLINIC HAS REPORTED THE FOLLOWING EVENT : "DURING THE INTERVENTION, SCREW MISMATCH AND THE SCREW HOLDER BY DEFORMATION OF THE CEPHALIC SCREW. TO COMPLETE THE PROCEDURE A CHANGE OF HEAD SCREW WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8461808 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K955306. One submission often covers many models, so check the product and lot details in each record.

• Z-1865-2008 · Jan 25, 2005 · Terminated
  Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plate