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Nuvasive Flarehawk Interbody Fusion

No active recall

Manufacturer: Nuvasive  · FDA product code: MAX  · Category: Intervertebral Fusion Device With Bone Graft, Lumbar

Severity Snapshot

67 total reports2018-022025-09 date range64.2% physician / facility reported35.8% manufacturer reported3 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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