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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spacer, cement
Product CodeLTO
Regulation Number 888.3320
Device Class 3

MDR Year MDR Reports MDR Events
2019 6 6
2020 3 3
2021 17 17
2022 3 3
2023 1 1
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 20 20
Use of Device Problem 6 6
Migration 3 3
Appropriate Term/Code Not Available 2 2
Loss of or Failure to Bond 2 2
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Unspecified Infection 11 11
Insufficient Information 8 8
No Code Available 7 7
Pain 6 6
Pulmonary Embolism 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Joint Laxity 2 2
Arrhythmia 2 2
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
Adhesion(s) 1 1
Thrombosis/Thrombus 1 1
Necrosis 1 1
Pneumonia 1 1
Loss of Range of Motion 1 1
Scar Tissue 1 1
Swelling 1 1
Thrombosis 1 1
Vomiting 1 1
Distress 1 1
Osteolysis 1 1
Post Operative Wound Infection 1 1
Inadequate Osseointegration 1 1
Foreign Body In Patient 1 1
Unspecified Tissue Injury 1 1
No Clinical Signs, Symptoms or Conditions 1 1

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