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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement, ossicular (stapes) using absorbable gelatin material
Regulation Description Partial ossicular replacement prosthesis.
Product CodeLBP
Regulation Number 874.3450
Device Class 2

MDR Year MDR Reports MDR Events
2022 1 1
2024 3 3
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Remains Activated 1 1
Decreased Pump Speed 1 1
Failure to Sense 1 1
Patient Device Interaction Problem 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Pump 1 1
Protective Measures Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
Cardiac Perforation 1 1
Syncope/Fainting 1 1
Heart Block 1 1

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