TPLC - Total Product Life Cycle

• Device: instrument, surgical, sonic and accessory/attachment
• Product Code: JDX
• Regulation Number: 888.4580
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
MORLEY RESEARCH CONSORTIUM
	SUBSTANTIALLY EQUIVALENT	1
SMTP TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	42	42
2019	34	34
2020	11	11
2021	7	7
2022	10	10
2023	5	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Electrical /Electronic Property Problem	40	40
Break	16	16
Fracture	16	16
Material Integrity Problem	11	11
Mechanical Problem	9	9
Device Inoperable	8	8
Defective Component	2	2
Energy Output Problem	2	2
Entrapment of Device	2	2
Fire	1	1
Detachment Of Device Component	1	1
Overheating of Device	1	1
Device-Device Incompatibility	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Twisted/Bent	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Packaging Problem	1	1
Noise, Audible	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	36	36
No Known Impact Or Consequence To Patient	25	25
No Clinical Signs, Symptoms or Conditions	14	14
No Consequences Or Impact To Patient	11	11
No Information	9	9
Foreign Body In Patient	5	5
Oversedation	4	4
Device Embedded In Tissue or Plaque	4	4
Insufficient Information	2	2
Pain	2	2
Discomfort	2	2
Burn, Thermal	1	1
No Patient Involvement	1	1
Patient Problem/Medical Problem	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Zimmer Biomet, Inc.	II	Jul-12-2019