TPLC - Total Product Life Cycle

• Device: retractor, self-retaining
• Product Code: FFO
• Regulation Number: 876.4730
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2015	2	2
2016	32	32
2017	20	20
2018	2	2
2019	4	4
2020	2	2
2022	3	3
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Dislodged or Dislocated	21	21
Unintended Movement	19	19
Break	12	12
Device Slipped	11	11
Mechanical Problem	6	6
Loose or Intermittent Connection	3	3
Component or Accessory Incompatibility	3	3
Device Operates Differently Than Expected	2	2
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Material Too Soft/Flexible	1	1
Excessive Heating	1	1
Separation Problem	1	1
Failure to Clean Adequately	1	1
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1
Packaging Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Device Maintenance Issue	1	1
Use of Device Problem	1	1
Defective Component	1	1
Component Missing	1	1
Arcing	1	1
Unsealed Device Packaging	1	1
Product Quality Problem	1	1
Shipping Damage or Problem	1	1
Device Reprocessing Problem	1	1
Contamination	1	1
Material Fragmentation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	55	55
No Consequences Or Impact To Patient	6	6
No Clinical Signs, Symptoms or Conditions	4	4
Burn(s)	1	1
Patient Problem/Medical Problem	1	1
No Information	1	1
Pregnancy	1	1
Insufficient Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Abeon Medical Corporation	II	Jan-21-2016