TPLC - Total Product Life Cycle

• Device: alloy, amalgam
• Product Code: EJJ
• Regulation Number: 872.3070
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	5	5
2015	4	4
2016	2	2
2018	3	3
2019	1	1
2020	1	1
2021	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	4	4
Fracture	3	3
Patient-Device Incompatibility	3	3
Occlusion Within Device	2	2
Component Missing	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Appropriate Term/Code Not Available	1	1
Leak/Splash	1	1
Device Ingredient or Reagent Problem	1	1
Device Operates Differently Than Expected	1	1
Improper Chemical Reaction	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Toxicity	4	4
Anxiety	3	3
Complaint, Ill-Defined	3	3
No Code Available	3	3
Confusion/ Disorientation	2	2
No Known Impact Or Consequence To Patient	2	2
No Information	2	2
Disability	2	2
Pain	2	2
Fatigue	2	2
Hair Loss	1	1
Headache	1	1
Memory Loss/Impairment	1	1
Neurological Deficit/Dysfunction	1	1
Autoimmune Disorder	1	1
Autoimmune Reaction	1	1
Bacterial Infection	1	1
Emotional Changes	1	1
Thyroid Problems	1	1
Blurred Vision	1	1
Twitching	1	1
Numbness	1	1
Diaphoresis	1	1
Shaking/Tremors	1	1
Test Result	1	1
Chemical Exposure	1	1
Cancer	1	1
Speech Disorder	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ivoclar Vivadent, Inc.	II	Feb-07-2024
2	Kerr Corporation	II	Jun-13-2014