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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 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Patient-Device Incompatibility 649 649
Sharp Edges 164 164
Adverse Event Without Identified Device or Use Problem 94 94
Inadequacy of Device Shape and/or Size 62 62
Unintended Movement 34 34
Lack of Effect 26 26
Device Appears to Trigger Rejection 19 19
Structural Problem 17 17
Break 10 10
Fitting Problem 7 7
Crack 7 7
Patient Device Interaction Problem 3 3
Pressure Problem 2 2
Insufficient Information 2 2
Material Fragmentation 2 2
Failure to Read Input Signal 1 1
Radiation Output Problem 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Deformity/ Disfigurement 423 423
Tooth Fracture 219 219
Laceration(s) 158 158
Tissue Breakdown 146 146
Pain 125 125
Sensitivity of Teeth 72 72
Bacterial Infection 55 55
Inflammation 40 40
Loss of Range of Motion 37 37
Discomfort 33 33
Muscular Rigidity 32 32
Insufficient Information 25 25
Hemorrhage/Bleeding 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Immobility of the joint 22 22
Hypersensitivity/Allergic reaction 20 20
Unspecified Infection 20 20
Blister 14 14
Increased Sensitivity 13 13
Difficulty Chewing 12 12
Unspecified Musculoskeletal problem 10 10
Necrosis 10 10
Stomatitis 6 6
Post Traumatic Wound Infection 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Swelling/ Edema 3 3
Pressure Sores 3 3
Erosion 2 2
Skin Inflammation/ Irritation 2 2
Contact Dermatitis 2 2
Nodule 2 2
Hair Loss 1 1
Headache 1 1
Keratitis 1 1
Nerve Damage 1 1
Scar Tissue 1 1
Skin Discoloration 1 1
Ulcer 1 1
Abscess 1 1
Osteolysis 1 1
Numbness 1 1
Choking 1 1
Osteopenia/ Osteoporosis 1 1
Localized Skin Lesion 1 1

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