NeuroMAUDE
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Tsrh Spinal

No active recall

FDA product code: KWP  · Category: Appliance, Fixation, Spinal Interlaminal

Severity Snapshot

445 total reports1994-112025-12 date range0.7% physician / facility reported99.3% manufacturer reported3 SKU variants

Failure & Consequence Profiles

Top Failure Modes

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Top Patient Outcomes

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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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