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TPLC
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Device
positioner, tooth, preformed
Product Code
KMY
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
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
87
87
Inadequacy of Device Shape and/or Size
9
9
Insufficient Information
2
2
Patient-Device Incompatibility
2
2
Problem with Sterilization
1
1
Melted
1
1
Crack
1
1
Break
1
1
Patient Device Interaction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Tooth Fracture
64
64
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Deformity/ Disfigurement
7
7
Necrosis
5
5
Post Traumatic Wound Infection
3
3
Tissue Breakdown
2
2
No Known Impact Or Consequence To Patient
1
1
Unspecified Musculoskeletal problem
1
1
No Consequences Or Impact To Patient
1
1
Sensitivity of Teeth
1
1
Hypersensitivity/Allergic reaction
1
1
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