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Integra Duraflex Suturable Dural Graft

No active recall

Manufacturer: Integra  · FDA product code: GXQ  · Category: Dura Substitute

Severity Snapshot

12 total reports2020-092026-02 date range100% physician / facility reported0% 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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