NeuroMAUDE
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Ultra Fast-Fix Assembly

No active recall

FDA product code: GAT  · Category: Suture, Nonabsorbable, Synthetic, Polyethylene

Severity Snapshot

1,105 total reports2012-012026-03 date range22% physician / facility reported78% manufacturer reported6 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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