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FR 50710）。","本品はクラスIIIに分類される医療機器であり、米国では市販前承認（PMA）による審査が求められます。クラスIIIは人体へのリスクが最も高い区分とされており、有効性及び安全性を裏付ける詳細な科学的データの提出と審査当局による承認が必要とされます。","claude-sonnet-5","af187ca2fb3532db75a8567731d1ac4374eee97d5a71220470bd20d997afcd22","2026-08-24T02:08:40.973135+00:00",{"product_code":6,"summary_ja":137,"stats":138,"stats_hash":155,"model_name":133,"created_at":156,"updated_at":156},"不具合報告（MDR）は累計約6,700件で、内訳は死亡が5件、傷害が約6,000件、不具合（Malfunction）が約450件、その他が約250件となっており、傷害の報告が大半を占めています。直近5年間の報告件数は約10件で、最新の報告は2024年4月です。主な問題としては、Osseointegration Problem（オッセオインテグレーション問題）、Mechanical Problem（機械的問題）、Patient Device Interaction 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