OMEGA 704047Recalls & reported problems
Stryker GmbH · One-Step Insertion Wrench - non-modular · Class 1
All models of OMEGA (20)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613154334988), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2019Break
THE 'TEETH' AT THE BASE OF THE OMEGA LAG SCREW SHEARED OFF DURING INSERTION WITH THE 'ONE PIECE LAG SCREW INSERTER (- 704047), WHICH WAS ALSO DAMAGED. THIS WAS IDENTIFIED DURING THE PROCEDURE, AND UPON INSPECTION POST PROCEDURE, THE ISSUE WAS IDENTIFIED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8451269 ↗
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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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