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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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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
Premarket Reviews
Manufacturer
Decision
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
117
117
2017
46
46
2018
56
56
2019
49
49
2020
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
136
136
Adverse Event Without Identified Device or Use Problem
98
98
Device-Device Incompatibility
32
32
Unintended Movement
21
21
Migration or Expulsion of Device
8
8
Device Slipped
7
7
Detachment of Device or Device Component
6
6
Material Deformation
6
6
Bent
5
5
Migration
4
4
No Apparent Adverse Event
3
3
Insufficient Information
3
3
Packaging Problem
3
3
Material Twisted/Bent
2
2
Appropriate Term/Code Not Available
2
2
Corroded
2
2
Crack
2
2
Mechanical Problem
1
1
Failure To Adhere Or Bond
1
1
Difficult To Position
1
1
Material Integrity Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Device Operates Differently Than Expected
1
1
Use of Device Problem
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Operating System Becomes Nonfunctional
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
139
139
Failure of Implant
107
107
Non-union Bone Fracture
87
87
Unspecified Infection
46
46
Pain
44
44
Impaired Healing
26
26
Bone Fracture(s)
18
18
No Consequences Or Impact To Patient
12
12
Reaction
9
9
Discomfort
7
7
Swelling
5
5
No Patient Involvement
5
5
No Clinical Signs, Symptoms or Conditions
3
3
No Information
3
3
Injury
3
3
Arthritis
3
3
Calcium Deposits/Calcification
2
2
Death
2
2
Irritation
2
2
Device Embedded In Tissue or Plaque
2
2
Not Applicable
2
2
Joint Dislocation
2
2
Osteolysis
2
2
Ambulation Difficulties
1
1
No Known Impact Or Consequence To Patient
1
1
Ischemia
1
1
Inflammation
1
1
Dysphagia/ Odynophagia
1
1
Fall
1
1
Sedation
1
1
Loss of Range of Motion
1
1
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