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