GAMMA 3066-0100SRecalls & reported problems
Stryker GmbH · U-Blade Set, Ti · Class 2 · Implant
All models of GAMMA (249)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540596000), received between Aug 25, 2020 and Mar 11, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Migration2
Patient problems
- Perforation2
- Failure of Implant1
- Implant Pain1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 11, 2025Migration; Migration
AS REPORTED: "PENETRATION OF THE GAMMA3 U-LAG SCREW WAS OCCURRED".
Patient problems: Perforation
MAUDE report 21580271 ↗InjuryAug 25, 2020Migration; Migration
AS REPORTED: "IN A REGULAR INSPECTION, IT WAS CONFIRMED THAT THE U LAG SCREW OF GAMMA3 WAS PENETRATING. WE DON'T KNOW THE CAUSE. IT SEEMS THAT THERE WAS ONE FALL. THE PATIENT'S SYMPTOM IS MILD PAIN."
Patient problems: Failure of Implant; Implant Pain; Pain; Perforation
MAUDE report 10451818 ↗
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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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