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TPLC
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Device
condylar plate fixation implant
Regulation Description
Single/multiple component metallic bone fixation appliances and accessories.
Product Code
JDP
Regulation Number
888.3030
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
56
56
2021
79
79
2022
61
61
2023
29
29
2024
30
30
2025
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
90
90
Adverse Event Without Identified Device or Use Problem
89
89
Device-Device Incompatibility
55
55
Material Twisted/Bent
13
13
Device Slipped
7
7
Material Deformation
5
5
Migration
5
5
Packaging Problem
3
3
Use of Device Problem
2
2
Fitting Problem
1
1
Detachment of Device or Device Component
1
1
Crack
1
1
Insufficient Information
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Non-union Bone Fracture
64
64
No Clinical Signs, Symptoms or Conditions
55
55
No Code Available
36
36
Pain
31
31
Unspecified Infection
27
27
Insufficient Information
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
21
21
Failure of Implant
17
17
Bone Fracture(s)
15
15
Malunion of Bone
12
12
No Consequences Or Impact To Patient
6
6
Fall
3
3
Unspecified Tissue Injury
3
3
Injury
2
2
Ambulation Difficulties
2
2
Physical Asymmetry
2
2
Swelling/ Edema
2
2
Loss of Range of Motion
2
2
No Patient Involvement
2
2
Thrombosis/Thrombus
2
2
Deformity/ Disfigurement
1
1
Impaired Healing
1
1
Reaction
1
1
Arthritis
1
1
Erythema
1
1
Limb Fracture
1
1
Necrosis
1
1
Nerve Damage
1
1
Local Reaction
1
1
Not Applicable
1
1
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