OMEGA 704004Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613153054436), received between Aug 20, 2015 and Feb 14, 2020 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 14, 2020Fracture; Fracture

  THE CUSTOMER REPORTS THAT THE SCREW THREAD BROKE OFF FROM THE PRODUCT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711072 ↗
• MalfunctionDec 26, 2019Fracture; Fracture

  THE CUSTOMER REPORTS THAT THE SCREW THREAD BROKE OFF FROM THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521809 ↗
• InjuryOct 30, 2019Break; Fracture; Fracture

  THE CUSTOMER REPORTED THAT ONE OF THE CONNECTING BOLTS ON THE DHS TRAY 704004, HAS SNAPPED OFF INSIDE A PATIENT DURING A PROCEDURE. THIS COULD NOT BE REMOVED AND HAS BEEN LEFT IN THE PATIENT. **UPDATE** THE CASE WAS COMPLETED WITH EXTENDED INCISION. THERE WAS A SURGICAL DELAY OF 15 MINUTES. THE EVENT HAPPENED WHILST THE LAG SCREW WAS BEING INSERTED INTO THE BONE, THE METAL OF THE CONNECTING BOLT SHEARED OFF IN THE LAG SCREW AT POINT OF CONTACT WITH INSERTION HANDLE. THE PATIENT WAS AN ELDERLY GENTLEMAN AND THE BONE WAS NOT PARTICULARLY HARD, THE SURGEON WAS NOT INSERTING THE LAG SCREW AT AN EXTREME ANGLE. SURGEON DID NOT ATTEMPT TO REMOVE THE BOLT. **UPDATE** THE SURGEON FURTHER REPORTED: ~15 CM WAS USED. I EXTENDED PROXIMALLY BY ~5CM TO GAIN A BETTER VIEW OF THE SCREW END AND ALLOW ME TO USE THE PLATE TO TURN THE SCREW. 4-6CM INCISION FOR A DHS WOULD BE APPROPRIATE FOR A 2 HOLE PLATE. NORMAL INCISION FOR A 4 HOLE PLATE IS IN THE REGION OF ~10 CM. ALTHOUGH IT CAN BE DONE VIA A MINIMALLY INVASIVE THIS IS NOT STANDARD PRACTICE IN (B)(6). EVENT OCCURRED DURING INSERTION OF THE SCREW AND WITH A NORMAL DEGREE OF TURNING ON THE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque; Injury

  MAUDE report 9258105 ↗
• MalfunctionOct 1, 2018Break

  PICKED INSTRUMENTS UP FROM HOSPITAL. THEY WERE USED IN A CASE WHERE STRYKER OMEGA IMPLANTS WERE REMOVED. REPLACEMENT IMPLANTS WERE USED, BUT FROM ANOTHER COMPANY. NO REP WAS PRESENT, BUT ALL IMPLANTS REMOVED SUCCESSFULLY. T HANDLE AND LAG SCREW INSERTER STUCK TOGETHER. CONNECTING BOLT THREADS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7924067 ↗
• MalfunctionJul 23, 2018Break

  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 7712311 ↗
• 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 5019187 ↗