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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
tissue graft of 6mm and greater
Product Code
LXA
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2
1
0
2
2
7
1
2
1
6
0
1
0
1
4
0
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
9
9
2016
11
11
2017
13
13
2018
11
11
2019
13
13
2020
3
3
2021
6
6
2022
8
8
2023
12
12
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Integrity Problem
25
25
Leak/Splash
13
13
Material Puncture/Hole
11
11
Insufficient Information
10
10
Obstruction of Flow
6
6
Fluid/Blood Leak
4
4
Hole In Material
4
4
Human Factors Issue
4
4
Device Packaging Compromised
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Contamination /Decontamination Problem
3
3
Contamination
2
2
Device Operates Differently Than Expected
2
2
Occlusion Within Device
2
2
Physical Property Issue
2
2
Device Handling Problem
1
1
Facilities Issue
1
1
Human-Device Interface Problem
1
1
Improper Flow or Infusion
1
1
Structural Problem
1
1
Device Markings/Labelling Problem
1
1
Bent
1
1
Break
1
1
Material Rupture
1
1
Inadequacy of Device Shape and/or Size
1
1
Inadequate or Insufficient Training
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
19
19
No Clinical Signs, Symptoms or Conditions
12
12
Aneurysm
9
9
Hemorrhage/Bleeding
7
7
Post Operative Wound Infection
7
7
Pseudoaneurysm
6
6
Insufficient Information
5
5
Bacterial Infection
5
5
Hematoma
5
5
Thrombus
5
5
Unspecified Infection
4
4
No Consequences Or Impact To Patient
4
4
No Patient Involvement
3
3
Thrombosis/Thrombus
3
3
Seroma
3
3
Occlusion
2
2
Thrombosis
2
2
Hyperplasia
2
2
Failure of Implant
2
2
Death
2
2
No Code Available
2
2
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Discharge
1
1
Discomfort
1
1
Blood Loss
1
1
Abscess
1
1
Cellulitis
1
1
Irritation
1
1
Ischemia
1
1
Vasodilatation
1
1
Staphylococcus Aureus
1
1
Swelling
1
1
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