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

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 24 24
Break 20 20
Crack 9 9
Material Deformation 5 5
Adverse Event Without Identified Device or Use Problem 4 4
Device-Device Incompatibility 3 3
Naturally Worn 2 2
Detachment of Device or Device Component 2 2
Leak/Splash 2 2
Scratched Material 1 1
Difficult to Insert 1 1
Mechanical Jam 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
Insufficient Information 5 5
Back pain 3 3
Device Embedded In Tissue or Plaque 2 2
Bone Fracture(s) 2 2
Vertebral Fracture 2 2
Extravasation 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Inflammation 1 1
Abscess 1 1
Muscle Weakness/Atrophy 1 1
Dysphagia/ Odynophagia 1 1
Nausea 1 1
Oversedation 1 1
Spinal Cord Injury 1 1
Ambulation or Postural Difficulties 1 1
Foreign Body In Patient 1 1

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