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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instrument, bending or contouring
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXP
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 19 19
2022 11 11
2023 5 5
2024 8 8
2025 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Device-Device Incompatibility 11 11
Mechanical Problem 7 7
Connection Problem 2 2
Mechanical Jam 2 2
Material Split, Cut or Torn 1 1
Entrapment of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Material Deformation 1 1
Fracture 1 1
Difficult to Open or Close 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 43 43
Insufficient Information 4 4
Foreign Body In Patient 1 1

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