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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filler, bone void, non-osteoinduction
Product CodeMBS
Device Class 3

MDR Year MDR Reports MDR Events
2023 4 4
2024 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Migration 17 17
Microbial Contamination of Device 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 2 2
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 9 9
Seroma 4 4
Fungal Infection 3 3
Fluid Discharge 3 3
Inflammation 2 2
Osteolysis 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Hypersensitivity/Allergic reaction 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Hematoma 1 1
Post Traumatic Wound Infection 1 1
Fall 1 1
Limb Fracture 1 1
Malunion of Bone 1 1
Nodule 1 1
Intervertebral Disc Compression or Protrusion 1 1

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