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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retainer, screw expansion, orthodontic
Regulation Description Orthodontic appliance and accessories.
Product CodeDYJ
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 5 5
2023 11 11
2024 3 3
2025 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 15 15
Adverse Event Without Identified Device or Use Problem 6 6
Patient Device Interaction Problem 2 2
Detachment of Device or Device Component 2 2
Break 1 1
Mechanical Problem 1 1
Patient-Device Incompatibility 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Failure of Implant 2 2
Foreign Body In Patient 2 2
Unspecified Infection 1 1
Unspecified Gastrointestinal Problem 1 1
Bone Fracture(s) 1 1
Blister 1 1
Deposits 1 1
Discomfort 1 1
Osteolysis 1 1
Insufficient Information 1 1
Loss of Range of Motion 1 1
Pain 1 1
Salivary Hypersecretion 1 1
Joint Contracture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brius Technologies Inc. II Apr-07-2022
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