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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, hearing, active, middle ear, partially implanted
Product CodeMPV
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 1 0 0 0 0

MDR Year MDR Reports MDR Events
2021 67 67
2022 52 53
2023 68 68
2024 80 80
2025 91 91
2026 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
No Device Output 108 108
Migration 86 86
Output Problem 67 67
Adverse Event Without Identified Device or Use Problem 63 64
Device Appears to Trigger Rejection 60 60
Insufficient Information 50 50
Lack of Effect 7 7
Improper or Incorrect Procedure or Method 7 7
Noise, Audible 6 6
Malposition of Device 2 2
Positioning Problem 2 2
Incomplete or Inadequate Connection 1 1
Intermittent Energy Output 1 1
Microbial Contamination of Device 1 1
No Apparent Adverse Event 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Failure of Implant 221 221
No Clinical Signs, Symptoms or Conditions 109 109
Skin Tears 34 34
Insufficient Information 29 30
Tissue Breakdown 26 26
Unspecified Infection 10 10
Implant Pain 8 8
Bacterial Infection 8 8
Head Injury 5 5
Total Hearing Loss 5 5
Pressure Sores 3 3
Wound Dehiscence 3 3
Pain 3 3
Discomfort 2 2
Skin Infection 2 2
Necrosis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Impaired Healing 1 1
Meningitis 1 1
Post Operative Wound Infection 1 1
Tinnitus 1 1
Perforation of Vessels 1 2
Dizziness 1 1
Erosion 1 1
Bone Fracture(s) 1 1

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