TPLC - Total Product Life Cycle

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Device	dental amalgam
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	7	7
Adverse Event Without Identified Device or Use Problem	2	2
Environmental Compatibility Problem	1	1
Gas/Air Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	4	4
Hypersensitivity/Allergic reaction	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Cognitive Changes	3	3
Fatigue	3	3
Anxiety	3	3
Malaise	3	3
Inflammation	2	2
Tics/Tremor	2	2
Twitching	2	2
Dysphasia	2	2
Unspecified Eye / Vision Problem	2	2
Emotional Changes	2	2
Toxicity	2	2
Shaking/Tremors	2	2
Depression	2	2
Speech Disorder	2	2
Weight Changes	2	2
Patient Problem/Medical Problem	1	1
Urinary Tract Infection	1	1
Tinnitus	1	1
Myocardial Infarction	1	1
Swelling/ Edema	1	1
Eczema	1	1
Taste Disorder	1	1
Itching Sensation	1	1
Headache	1	1
Vomiting	1	1
Dizziness	1	1
Chest Pain	1	1
Unspecified Gastrointestinal Problem	1	1
Fungal Infection	1	1
Failure of Implant	1	1
Immunodeficiency	1	1
Deformity/ Disfigurement	1	1
Swollen Lymph Nodes/Glands	1	1
Hair Loss	1	1
Tissue Breakdown	1	1
No Code Available	1	1
Irritability	1	1
Nausea	1	1
Thyroid Problems	1	1
Death	1	1
Foreign Body In Patient	1	1
Unspecified Tissue Injury	1	1
Confusion/ Disorientation	1	1
Suicidal Ideation	1	1
Chills	1	1
Convulsion/Seizure	1	1
Multiple Organ Failure	1	1