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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 reports2012-04 – 2026-02 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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