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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
2020 8 8
2021 7 7
2022 5 5
2023 4 4
2024 10 10
2025 25 25
2026 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 25 25
Break 22 22
Crack 9 9
Leak/Splash 5 5
Material Deformation 5 5
Device-Device Incompatibility 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Detachment of Device or Device Component 2 2
Naturally Worn 2 2
Burst Container or Vessel 1 1
Scratched Material 1 1
Inflation Problem 1 1
Mechanical Jam 1 1
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 44 44
Insufficient Information 6 6
No Known Impact Or Consequence To Patient 3 3
Extravasation 3 3
Bone Fracture(s) 2 2
Device Embedded In Tissue or Plaque 2 2
Nausea 1 1
Inflammation 1 1
Muscle Weakness 1 1
Oversedation 1 1
Foreign Body In Patient 1 1
Abscess 1 1
Dysphagia/ Odynophagia 1 1
No Consequences Or Impact To Patient 1 1
Spinal Cord Injury 1 1
Vertebral Fracture 1 1

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