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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
Product CodeLBP
Regulation Number 874.3450
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2022 1 1
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Remains Activated 1 1
Decreased Pump Speed 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2 2
Syncope/Fainting 1 1
No Code Available 1 1
Cardiac Perforation 1 1
Burn(s) 1 1
Heart Block 1 1

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