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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
2015 2 2
2016 2 2
2018 5 5
2019 3 3
2021 71 71
2022 19 19
2023 4 4
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 89 89
Inadequacy of Device Shape and/or Size 16 16
Patient-Device Incompatibility 6 6
Insufficient Information 4 4
Device Appears to Trigger Rejection 2 2
Break 2 2
Crack 1 1
Fracture 1 1
Melted 1 1
Problem with Sterilization 1 1
Improper or Incorrect Procedure or Method 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Tooth Fracture 65 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Deformity/ Disfigurement 11 11
Necrosis 5 5
Tissue Breakdown 4 4
Hypersensitivity/Allergic reaction 4 4
Post Traumatic Wound Infection 3 3
Pain 3 3
Swelling 2 2
No Consequences Or Impact To Patient 2 2
Ulcer 1 1
Tinnitus 1 1
Burning Sensation 1 1
Rash 1 1
Erythema 1 1
Bone Fracture(s) 1 1
Headache 1 1
Palpitations 1 1
Sensitivity of Teeth 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Unspecified Musculoskeletal problem 1 1

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