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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stimulator, invasive bone growth
Product CodeLOE
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
2 4 0 1 0 0

MDR Year MDR Reports MDR Events
2021 3 3
2023 2 2
2024 2 2
2025 7 7
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Patient-Device Incompatibility 3 3
Insufficient Device Problem Information 3 3
Appropriate Device Problem Term/Code Not Available 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9 9
Insufficient Information 3 3
Unspecified Infection 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Paralysis 2 2
Impaired Healing 1 1
Drug Resistant Bacterial Infection 1 1
Sepsis 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Skin Inflammation/ Irritation 1 1
Post Operative Wound Infection 1 1
Back pain 1 1
Osteomyelitis 1 1
Erythema 1 1
Fall 1 1
Balance Problems 1 1
Bruise/Contusion 1 1
Urinary Tract Infection 1 1

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