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Stryker Elite
No active recall
Manufacturer: Stryker · FDA product code: HBE · Category: Drills, Burrs, Trephines & Accessories (Simple, Powered)
Severity Snapshot
1,384 total reports2000-01 – 2026-01 date range0.2% physician / facility reported99.8% manufacturer reported14 SKU variants
Failure & Consequence Profiles
Top Failure Modes
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Top Patient Outcomes
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Reporting Trend
Annual Reporting Volume
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Note: the 2018 Voluntary Malfunction Summary Reporting expansion means volume increases may reflect surveillance changes, not increased device risk.
Reported Events
Submitted to FDA MAUDE by physicians, hospitals, manufacturers, and patients.
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