TPLC - Total Product Life Cycle

• Device: clip, scalp
• Product Code: HBO
• Regulation Number: 882.4150
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2014	3	3
2015	4	4
2016	4	4
2017	12	12
2018	4	4
2019	12	12
2020	2	2
2021	5	5
2022	3	3
2023	3	3
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Compatibility Problem	11	11
Device Contamination with Chemical or Other Material	7	7
Break	6	6
Incorrect Device Or Component Shipped	5	5
Packaging Problem	3	3
Insufficient Information	2	2
Appropriate Term/Code Not Available	2	2
Component Missing	2	2
Failure to Fire	2	2
Contamination /Decontamination Problem	2	2
Device Operates Differently Than Expected	2	2
Material Fragmentation	2	2
Mechanical Problem	1	1
Unsealed Device Packaging	1	1
Peeled/Delaminated	1	1
Component Falling	1	1
Contamination	1	1
Crack	1	1
Material Discolored	1	1
Device-Device Incompatibility	1	1
Difficult to Open or Remove Packaging Material	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Failure to Eject	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	19	19
No Information	15	15
No Clinical Signs, Symptoms or Conditions	8	8
Foreign Body In Patient	4	4
Unspecified Infection	2	2
No Consequences Or Impact To Patient	2	2
No Code Available	2	2
Device Embedded In Tissue or Plaque	1	1
Failure to Anastomose	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Integra LifeSciences Corp.	II	Aug-06-2021
2	Medtronic Neurosurgery	II	Sep-21-2018
3	Medtronic Neurosurgery	II	Feb-15-2018