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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device tamp
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXG
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2019 15 15
2020 8 8
2021 7 7
2022 5 5
2023 4 4
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Break 18 18
Material Rupture 15 15
Crack 7 7
Leak/Splash 5 5
Device-Device Incompatibility 4 4
Material Deformation 4 4
Detachment of Device or Device Component 2 2
Naturally Worn 2 2
Fluid/Blood Leak 2 2
Burst Container or Vessel 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Inflation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
Extravasation 2 2
Bone Fracture(s) 1 1
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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