TPLC - Total Product Life Cycle

• Device: bracket, metal, orthodontic
• Product Code: EJF
• Regulation Number: 872.5410
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2018	3	3
2019	1	1
2020	4	4
2021	1	1
2022	7	7
2023	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	5	5
Patient Device Interaction Problem	3	3
Sharp Edges	2	2
Insufficient Information	2	2
Biocompatibility	2	2
Use of Device Problem	2	2
Improper or Incorrect Procedure or Method	2	2
Separation Failure	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1
Appropriate Term/Code Not Available	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Tooth Fracture	8	8
Abrasion	3	3
Hypersensitivity/Allergic reaction	3	3
Nausea	2	2
Blurred Vision	2	2
Hot Flashes/Flushes	2	2
Dizziness	2	2
Foreign Body Reaction	2	2
Headache	2	2
Depression	2	2
Irritability	2	2
Shaking/Tremors	2	2
Sleep Dysfunction	2	2
Abdominal Pain	2	2
Foreign Body In Patient	1	1
Device Embedded In Tissue or Plaque	1	1
Syncope/Fainting	1	1
Speech Disorder	1	1
Metal Related Pathology	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Ulcer	1	1
Pressure Sores	1	1
Arthralgia	1	1
Visual Impairment	1	1
Vomiting	1	1
Diarrhea	1	1
Erythema	1	1
Fatigue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ormco/Sybronendo	II	Jun-05-2020
2	Ortho Organizers, Inc.	II	Jun-30-2020