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Integra Duraseal
No active recall
Manufacturer: Integra · FDA product code: NQR · Category: Sealant, Dural
Severity Snapshot
62 total reports2005-08 – 2025-11 date range22.4% physician / facility reported77.6% manufacturer reported7 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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