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Nuvasive SI Polyaxl Screw 6 X
No active recall
Manufacturer: Nuvasive · FDA product code: NKB · Category: Thoracolumbosacral Pedicle Screw System
Severity Snapshot
87 total reports2015-01 – 2025-10 date range23% physician / facility reported77% manufacturer reported5 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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