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Integra Duraseal Exact Spine Sealant

No active recall

Manufacturer: Integra  · FDA product code: NQR  · Category: Sealant, Dural

Severity Snapshot

78 total reports2012-042026-02 date range9.2% physician / facility reported90.8% 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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