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Medtronic Infuse Bone Graft

No active recall

Manufacturer: Medtronic  · FDA product code: NEK  · Category: Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

Severity Snapshot

12,050 total reports2003-032026-03 date range0.7% physician / facility reported99.3% manufacturer reported16 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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