TPLC - Total Product Life Cycle

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Device	dental amalgam
Regulation Description	Dental amalgam, mercury, and amalgam alloy.
Definition	Dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth
Product Code	OIV
Regulation Number	872.3070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Patient-Device Incompatibility	6	27
Adverse Event Without Identified Device or Use Problem	2	2
Environmental Compatibility Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Hypersensitivity/Allergic reaction	4	12
Pain	3	20
Malaise	3	7
Cognitive Changes	3	16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tics/Tremor	2	2
Speech Disorder	2	2
Unspecified Eye / Vision Problem	2	2
Depression	2	6
Shaking/Tremors	2	2
Weight Changes	2	2
Dysphasia	2	2
Anxiety	2	6
Inflammation	2	2
Twitching	2	2
Emotional Changes	2	6
Fatigue	2	15
Headache	1	1
Failure of Implant	1	1
Tinnitus	1	1
Urinary Tract Infection	1	1
Vomiting	1	1
Immunodeficiency	1	1
Chills	1	1
Dizziness	1	1
Itching Sensation	1	1
Nausea	1	1
Deformity/ Disfigurement	1	1
Tissue Breakdown	1	1
Foreign Body In Patient	1	1
Convulsion/Seizure	1	1
Chest Pain	1	1
Fungal Infection	1	1
Irritability	1	1
Unspecified Gastrointestinal Problem	1	1
Eczema	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Taste Disorder	1	5
Confusion/ Disorientation	1	5
Suicidal Ideation	1	1
Swollen Lymph Nodes/Glands	1	1