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Manufacturer: Nuvasive · FDA product code: NKB · Category: Thoracolumbosacral Pedicle Screw System
Severity Snapshot
422 total reports2014-09 – 2026-03 date range64.9% physician / facility reported35.1% manufacturer reported1 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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