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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implant, malar
Regulation Description Chin prosthesis.
Product CodeLZK
Regulation Number 878.3550
Device Class 2

MDR Year MDR Reports MDR Events
2020 1 1
2021 1 1
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 2 2
Insufficient Information 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Dry Eye(s) 1 1
Autoimmune Disorder 1 1
Post Operative Wound Infection 1 1
Numbness 1 1
Unspecified Eye / Vision Problem 1 1
Ecchymosis 1 1
Pain 1 1
Fluid Discharge 1 1
Swelling/ Edema 1 1
Headache 1 1
Eye Pain 1 1

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