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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tissue graft of 6mm and greater
Product CodeLXA
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 1 0 1 4 1

MDR Year MDR Reports MDR Events
2019 13 13
2020 3 3
2021 6 6
2022 8 8
2023 12 12
2024 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 25 25
Insufficient Information 12 12
Material Puncture/Hole 11 11
Contamination 2 2
Obstruction of Flow 2 2
Material Rupture 2 2
Device Damaged Prior to Use 1 1
Device Markings/Labelling Problem 1 1
Defective Component 1 1
Structural Problem 1 1
Device Handling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14 14
Insufficient Information 7 7
Aneurysm 6 6
Seroma 5 5
Thrombosis/Thrombus 5 5
No Known Impact Or Consequence To Patient 4 4
Pseudoaneurysm 4 4
Hemorrhage/Bleeding 4 4
Unspecified Infection 3 3
Hematoma 3 3
Post Operative Wound Infection 3 3
Bacterial Infection 3 3
No Consequences Or Impact To Patient 3 3
No Code Available 1 1
Rupture 1 1
No Patient Involvement 1 1

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