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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device stimulator, invasive bone growth
Product CodeLOE
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 2 4 0 1 0

MDR Year MDR Reports MDR Events
2020 5 5
2021 3 3
2023 2 2
2024 2 2
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3 3
Patient-Device Incompatibility 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Corroded 1 1
Appropriate Term/Code Not Available 1 1
Inaccurate Information 1 1
Disconnection 1 1
Material Discolored 1 1
Device Damaged by Another Device 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
Insufficient Information 3 3
No Code Available 2 2
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Unspecified Infection 1 1
Erythema 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Post Operative Wound Infection 1 1
Cramp(s) /Muscle Spasm(s) 1 1

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