NeuroMAUDE
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Stryker Standard Craniotome Black Max

No active recall

Manufacturer: Stryker  · FDA product code: GFF  · Category: Bur, Surgical, General & Plastic Surgery

Severity Snapshot

158 total reports2013-032019-06 date range0% physician / facility reported100% manufacturer reported2 SKU variants

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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