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Stryker Kyphx® Hv-R Bone Cement
No active recall
Manufacturer: Stryker · FDA product code: NDN · Category: Cement, Bone, Vertebroplasty
Severity Snapshot
242 total reports2010-12 – 2025-12 date range6.2% physician / facility reported93.8% manufacturer reported1 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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