TPLC - Total Product Life Cycle

• Device: light, operating, dental
• Product Code: EAZ
• Regulation Number: 872.4630
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	13	13
2015	13	13
2016	9	9
2017	11	11
2018	10	10
2019	4	4
2020	3	3
2021	8	8
2023	2	2
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Component Falling	27	27
Installation-Related Problem	13	13
Device Fell	12	12
Detachment Of Device Component	8	8
Break	7	7
Mechanical Problem	4	4
Device Maintenance Issue	4	4
Detachment of Device or Device Component	3	3
Defective Device	2	2
Misassembly During Maintenance/Repair	2	2
Device Handling Problem	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	1	1
Burst Container or Vessel	1	1
Unintended Collision	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Contusion	11	11
No Consequences Or Impact To Patient	10	10
No Known Impact Or Consequence To Patient	10	10
No Patient Involvement	7	7
No Clinical Signs, Symptoms or Conditions	6	6
Burn(s)	5	5
Laceration(s)	5	5
Swelling	5	5
Bruise/Contusion	4	4
Injury	4	4
Superficial (First Degree) Burn	3	3
Pain	3	3
Burning Sensation	2	2
Concussion	1	1
Spinal Column Injury	1	1
Abrasion	1	1
Bone Fracture(s)	1	1
Brain Injury	1	1
Neck Pain	1	1
Suture Abrasion	1	1
Burn, Thermal	1	1
No Code Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Dental Equipment LLC	II	Jul-15-2011
2	Pelton & Crane / Marus / DCI Equipment / KaVo	II	Mar-28-2016