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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device positioner, tooth, preformed
Regulation Description Preformed tooth positioner.
Product CodeKMY
Regulation Number 872.5525
Device Class 1

MDR Year MDR Reports MDR Events
2021 71 71
2022 19 19
2023 4 4
2024 376 376
2025 459 459
2026 706 706

Device Problems MDRs with this Device Problem Events in those MDRs
Sharp Edges 737 737
Patient-Device Incompatibility 702 702
Device Appears to Trigger Rejection 592 592
Defective Device 576 576
Adverse Event Without Identified Device or Use Problem 94 94
Inadequacy of Device Shape and/or Size 63 63
Unintended Movement 55 55
Lack of Effect 26 26
Structural Problem 17 17
Break 10 10
Fitting Problem 7 7
Crack 7 7
Application Program Freezes or Fails to Launch 4 4
Patient Device Interaction Problem 3 3
Pressure Problem 2 2
Insufficient Device Problem Information 2 2
Material Fragmentation 2 2
Intermittent Loss of Power 1 1
Difficult to Remove 1 1
Increase in Pressure 1 1
Unexpected Shutdown 1 1
Radiation Output Problem 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 1021 1021
Tooth Fracture 812 812
Laceration(s) 738 738
Hypersensitivity/Allergic reaction 593 593
Tooth Loss 593 593
Necrosis 583 583
Swelling/ Edema 577 577
Abscess 575 575
Tissue Breakdown 151 151
Pain 148 148
Sensitivity of Teeth 91 91
Bacterial Infection 60 60
Discomfort 44 44
Inflammation 40 40
Loss of Range of Motion 37 37
Muscular Rigidity 32 32
Hemorrhage/Blood Loss/Bleeding 25 25
Insufficient Information 25 25
Joint locking 23 23
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 23 23
Unspecified Infection 21 21
Unspecified Musculoskeletal problem 17 17
Blister 14 14
Hyperresponsive to stimuli 13 13
Difficulty Chewing 13 13
Stomatitis 8 8
Wound Infection 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Pressure Sore/Ulcer 3 3
Contact Dermatitis 2 2
Skin Inflammation/ Irritation 2 2
Nodule 2 2
Erosion 2 2
Localized Skin Lesion 1 1
Numbness 1 1
Hair Loss 1 1
Hyperglycemia 1 1
Abrasion 1 1
Headache 1 1
Skin Discoloration 1 1
Osteolysis 1 1
Nausea 1 1
Osteopenia/ Osteoporosis 1 1
Scar Tissue 1 1
Obstruction/Occlusion 1 1
Corneal Edema 1 1
Keratitis 1 1
Ulcer 1 1
Nerve Damage 1 1
Choking 1 1

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