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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
Product CodeDYJ
Regulation Number 872.5410
Device Class 1

MDR Year MDR Reports MDR Events
2019 8 8
2020 3 3
2021 6 6
2022 5 5
2023 11 11
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 17 17
Adverse Event Without Identified Device or Use Problem 5 5
Detachment of Device or Device Component 3 3
Patient-Device Incompatibility 2 2
Device Dislodged or Dislocated 1 1
Break 1 1
Collapse 1 1
Fracture 1 1
Mechanical Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 19 19
Foreign Body In Patient 6 6
Failure of Implant 2 2
Unspecified Infection 1 1
Inflammation 1 1
Pain 1 1
Swelling 1 1
Ulceration 1 1
Ulcer 1 1
Osteolysis 1 1
Reaction 1 1
Collapse 1 1
Sleep Dysfunction 1 1
No Code Available 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Deposits 1 1
Bone Fracture(s) 1 1

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