OMEGA 704002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613153054412), received between Aug 20, 2015 and Jul 23, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2018Break; Retraction Problem

  IT WAS REPORTED THAT DURING INSERTION OF THE LAG-SCREW USING THE ONE-STEP TECHNIQUE, AND PRIOR TO FULLY SEATING THE LAG SCREW, THE CONNECTING BOLT SHEARED OFF. DURING CONTINUED ATTEMPTS TO FULLY SEAT THE SCREW, THE LAG SCREW INTERLOCKING TABS SHEARED OFF. SUBSEQUENT ATTEMPTS TO FULLY SEAT OR REMOVE THE LAG SCREW WERE DIFFICULT. IT WAS REPORTED THAT ADDITIONAL OPERATIVE TIME WAS 30 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7712317 ↗
• MalfunctionAug 20, 2015Break

  THE CUSTOMER REPORTED THAT WHEN THE LAG SCREW WAS BEING INSERTED THE LAG SCREW SNAPPED OFF THE INSERTER. THE CUSTOMER REPORTED THAT THEY WERE USING THE ONE STEP INSERTION APPROACH AND THAT THE BONE WAS VERY HARD. THE CONSULTANT THOUGHT WITH HINDSIGHT THAT THEY SHOULD HAVE TAPPED BECAUSE OF THE HARDNESS OF THE BONE. AFTER THE SCREW SNAPPED A PIECE REMAINED IN THE PATIENT AND THIS WAS REMOVED USING A REDUCTION INSTRUMENT. ANOTHER SCREW WAS AVAILABLE TO COMPLETE THE CASE. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 20 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5019188 ↗