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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
2017 2 2
2018 12 12
2019 8 8
2020 3 3
2021 6 6
2022 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Insufficient Information 7 7
Patient-Device Incompatibility 5 5
Detachment of Device or Device Component 3 3
Break 2 2
Collapse 1 1
Contamination 1 1
Material Disintegration 1 1
Fracture 1 1
Mechanical Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Dislodged or Dislocated 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Reaction 10 10
Hypersensitivity/Allergic reaction 9 9
Burning Sensation 7 7
Foreign Body In Patient 7 7
Erythema 6 6
Swelling 4 4
Inflammation 3 3
Irritation 2 2
Itching Sensation 2 2
Dyspnea 2 2
Failure of Implant 2 2
Confusion/ Disorientation 2 2
Peeling 2 2
Weight Changes 1 1
Device Embedded In Tissue or Plaque 1 1
No Code Available 1 1
Collapse 1 1
Sweating 1 1
Sleep Dysfunction 1 1
Unspecified Infection 1 1
Arthritis 1 1
Dehydration 1 1
Deposits 1 1
Diarrhea 1 1
Pain 1 1
Ulceration 1 1
Tingling 1 1
Ulcer 1 1

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