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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)
2019 2020 2021 2022 2023 2024
4 0 2 4 0 0

MDR Year MDR Reports MDR Events
2019 10 10
2020 5 5
2021 3 3
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6 6
Insufficient Information 6 6
Patient-Device Incompatibility 5 5
Appropriate Term/Code Not Available 4 4
Device-Device Incompatibility 2 2
Microbial Contamination of Device 1 1
Device Damaged by Another Device 1 1
Material Discolored 1 1
Disconnection 1 1
Unexpected Therapeutic Results 1 1
Nonstandard Device 1 1
Inaccurate Information 1 1
Corroded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 12 12
Unspecified Infection 6 6
No Code Available 3 3
Insufficient Information 3 3
Swelling 2 2
Failure of Implant 1 1
Sepsis 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Necrosis 1 1
Test Result 1 1
No Information 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Post Operative Wound Infection 1 1
No Known Impact Or Consequence To Patient 1 1
Muscle Spasm(s) 1 1
Abscess 1 1
Lethargy 1 1

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