NeuroMAUDE
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Stryker Synflate Balloon Medium- Sterile

No active recall

Manufacturer: Stryker  · FDA product code: NDN  · Category: Cement, Bone, Vertebroplasty

Severity Snapshot

155 total reports2013-112026-03 date range88.4% physician / facility reported11.6% 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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