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TPLC
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show TPLC since
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Device
retainer, screw expansion, orthodontic
Product Code
DYJ
Regulation Number
872.5410
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2016
2
2
2017
2
2
2018
12
12
2019
8
8
2020
3
3
2021
6
6
2022
5
5
2023
11
11
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
18
18
Adverse Event Without Identified Device or Use Problem
16
16
Patient-Device Incompatibility
8
8
Detachment of Device or Device Component
4
4
Break
3
3
Patient Device Interaction Problem
2
2
Mechanical Problem
1
1
Material Fragmentation
1
1
Device Dislodged or Dislocated
1
1
Fracture
1
1
Material Disintegration
1
1
Collapse
1
1
Inadequacy of Device Shape and/or Size
1
1
Contamination
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
22
22
Reaction
10
10
Burning Sensation
7
7
Foreign Body In Patient
7
7
Erythema
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Swelling
4
4
Failure of Implant
3
3
Pain
3
3
Inflammation
3
3
Itching Sensation
3
3
Headache
2
2
Ulcer
2
2
Collapse
2
2
Peeling
2
2
Dyspnea
2
2
Confusion/ Disorientation
2
2
Irritation
2
2
Device Embedded In Tissue or Plaque
1
1
Ambulation Difficulties
1
1
Arthritis
1
1
Toxicity
1
1
Ulceration
1
1
Dehydration
1
1
Insufficient Information
1
1
Osteolysis
1
1
Discomfort
1
1
Diarrhea
1
1
Deposits
1
1
Cognitive Changes
1
1
Malaise
1
1
Head Injury
1
1
Bone Fracture(s)
1
1
Test Result
1
1
No Code Available
1
1
Fatigue
1
1
Sweating
1
1
Arthralgia
1
1
Tingling
1
1
Patient Problem/Medical Problem
1
1
Weight Changes
1
1
Sleep Dysfunction
1
1
Unspecified Infection
1
1
Abdominal Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Allesee Orthodontic Appliances
II
Apr-01-2014
2
Brius Technologies Inc.
II
Apr-07-2022
3
Ormco Corporation
II
Mar-05-2012
4
Sybron Dental Specialties
II
Sep-12-2013
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