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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
Product CodeKMY
Regulation Number 872.5525
Device Class 1

MDR Year MDR Reports MDR Events
2019 3 3
2021 71 71
2022 19 19
2023 4 4
2024 43 43

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 90 90
Inadequacy of Device Shape and/or Size 23 23
Sharp Edges 17 17
Patient-Device Incompatibility 7 7
Device Appears to Trigger Rejection 2 2
Insufficient Information 2 2
Break 1 1
Crack 1 1
Patient Device Interaction Problem 1 1
Problem with Sterilization 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 66 66
Tissue Breakdown 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
Laceration(s) 17 17
Deformity/ Disfigurement 15 15
Pain 7 7
Necrosis 5 5
Hypersensitivity/Allergic reaction 3 3
Post Traumatic Wound Infection 3 3
Inflammation 2 2
Unspecified Infection 1 1
Unspecified Musculoskeletal problem 1 1
No Known Impact Or Consequence To Patient 1 1
Headache 1 1
No Consequences Or Impact To Patient 1 1
Sensitivity of Teeth 1 1

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