OMEGA 704013Recalls & reported problems
Stryker GmbH · Fixed Angle Guide · Class 1
All models of OMEGA (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540451194), received between Jul 24, 2019 and Jun 4, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Fracture2
- Break1
- Detachment of Device or Device Component1
Patient problems
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJun 4, 2025Break; Fracture; Break; Fracture
AS REPORTED: "WE HAVE HAD AN OMEGA 2 GUIDE FOR 135 PLATES 704013 BREAK DURING USE AND PART OF THE INSTRUMENTS HAS GOTTEN STUCK INSIDE THE PATIENT, [...] WE HAVE ALSO NOTICED THAT THE SMALL METAL INSERT IS ALSO ON THE VARIABLE ANGLE GUIDE 704014."
Patient problems: Foreign Body In Patient
MAUDE report 22141606 ↗MalfunctionNov 20, 2019Fracture; Fracture
THE CUSTOMER REPORTED THAT WHEN THE SURGEON WAS COMPLETING A DHS WITH CANNULATED SCREWS, HE TRIED TO FEED A 3.2MM WIRE INTO A 2.8MM WIRE HOLE. THE WASHER ON THE ANGLE GUIDE HAS SUBSEQUENTLY BROKEN OFF AND GONE INTO THE PATIENT. THE CUSTOMER FURTHER REPORTED THAT ONE OF THE METALLIC TUBES WHICH GOT PUSHED OUT OF THE GUIDE INTO THE PATIENT. THEY WERE UNABLE TO RETRIEVE THE TUBE AND AFTER DISCUSSIONS WITH THE CONSULTANT SURGEON IN CHARGE THE DECISION WAS MADE TO LEAVE IT IN SITU AS REMOVING IT WOULD CAUSE MORE TRAUMA. THE PATIENT DID UNDERGO A LONGER OPERATION TIME DUE TO THE INCIDENT. ATTEMPTS WERE MADE TO REMOVE THE DEVICE. THE SURGICAL DELAY WAS 15 MINUTES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9345753 ↗MalfunctionJul 24, 2019Detachment of Device or Device Component
INNER SLEEVE OF THE TARGET DEVICE DETACHED AND STUCK IN THE PATIENT. THE INNER SLEEVE COULD BE REMOVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8824843 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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