Back to Cranial Surgery
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
Click any bar to view those reports ↓
Top Patient Outcomes
Click any bar to view those reports ↓
Reporting Trend
Annual Reporting Volume
Click any bar to view those reports ↓
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.
Filter by failure mode
Filter by outcome
Loading reports…