TPLC - Total Product Life Cycle

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Device	bracket, metal, orthodontic
Regulation Description	Orthodontic appliance and accessories.
Product Code	EJF
Regulation Number	872.5410
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	7	7
Insufficient Device Problem Information	3	3
Improper or Incorrect Procedure or Method	3	3
Biocompatibility	3	3
Patient Device Interaction Problem	2	2
Sharp Edges	2	2
Separation Failure	1	1
Detachment of Device or Device Component	1	1
Appropriate Device Problem Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Tooth Fracture	12	12
Hypersensitivity/Allergic reaction	6	6
Abrasion	3	3
Shaking/Tremors	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Abdominal Pain	2	2
Sleep Dysfunction	2	2
Nausea	2	2
No Code Available	2	2
Dizziness	2	2
Foreign Body Reaction	2	2
Tooth Loss	2	2
Depression	2	2
Blurred Vision	2	2
Headache	2	2
Hot Flashes/Flushes	2	2
Irritability	2	2
Syncope/Fainting	1	1
Arthralgia	1	1
Speech Disorder	1	1
Fatigue	1	1
Metal Related Pathology	1	1
Skin Inflammation/ Irritation	1	1
Cognitive Changes	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Neck Pain	1	1
Foreign Body In Patient	1	1
Diarrhea	1	1
Erythema	1	1
Vomiting	1	1
Visual Impairment	1	1
Pressure Sore/Ulcer	1	1
Swelling/ Edema	1	1
Ulcer	1	1
Inadequate Pain Relief	1	1
Joint Impingement	1	1
Device Embedded In Tissue or Plaque	1	1