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TPLC
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show TPLC since
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2019
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2024
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Device
wire, surgical
Product Code
LRN
Regulation Number
888.3030
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
57
57
2015
24
24
2016
38
38
2017
33
33
2018
58
58
2019
84
84
2020
68
68
2021
118
118
2022
106
106
2023
140
140
2024
46
46
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
272
272
Material Deformation
172
172
Adverse Event Without Identified Device or Use Problem
125
125
Device-Device Incompatibility
107
107
Entrapment of Device
79
79
Material Fragmentation
48
48
No Apparent Adverse Event
17
17
Device Operates Differently Than Expected
13
13
Material Twisted/Bent
8
8
Mechanical Jam
7
7
Difficult to Remove
6
6
Appropriate Term/Code Not Available
6
6
Bent
6
6
Migration
6
6
Device Slipped
5
5
Contamination /Decontamination Problem
4
4
Scratched Material
4
4
Device Handling Problem
4
4
Migration or Expulsion of Device
4
4
Material Integrity Problem
4
4
Sticking
3
3
Defective Device
3
3
Improper or Incorrect Procedure or Method
2
2
Overheating of Device
2
2
Packaging Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Insufficient Information
2
2
Difficult to Advance
2
2
Deformation Due to Compressive Stress
1
1
Loose or Intermittent Connection
1
1
Fracture
1
1
Device Dislodged or Dislocated
1
1
Metal Shedding Debris
1
1
Device Expiration Issue
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Unintended Movement
1
1
Crack
1
1
Peeled/Delaminated
1
1
Mechanical Problem
1
1
Material Protrusion/Extrusion
1
1
Biocompatibility
1
1
Detachment Of Device Component
1
1
Failure to Cut
1
1
Use of Device Problem
1
1
Device Difficult to Maintain
1
1
Failure to Align
1
1
Disconnection
1
1
Activation, Positioning or Separation Problem
1
1
Fitting Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
267
267
Foreign Body In Patient
91
91
No Code Available
87
87
No Consequences Or Impact To Patient
76
76
No Known Impact Or Consequence To Patient
68
68
Device Embedded In Tissue or Plaque
38
38
Pain
38
38
No Patient Involvement
35
35
Non-union Bone Fracture
30
30
Unspecified Infection
29
29
Insufficient Information
25
25
Post Operative Wound Infection
19
19
Failure of Implant
15
15
Unspecified Tissue Injury
14
14
Injury
14
14
Bone Fracture(s)
10
10
Sedation
8
8
Nerve Damage
8
8
Impaired Healing
6
6
Hypersensitivity/Allergic reaction
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Necrosis
5
5
Inflammation
5
5
Foreign Body Reaction
4
4
Discomfort
4
4
Wound Dehiscence
3
3
Swelling/ Edema
3
3
No Information
3
3
Skin Inflammation/ Irritation
3
3
Ambulation Difficulties
2
2
Arthritis
2
2
Bacterial Infection
2
2
Ulcer
2
2
Tissue Damage
2
2
Malunion of Bone
2
2
Swelling
2
2
Needle Stick/Puncture
2
2
Burn(s)
2
2
Rupture
2
2
Not Applicable
2
2
Limited Mobility Of The Implanted Joint
2
2
Erythema
1
1
Paralysis
1
1
Eye Injury
1
1
Abscess
1
1
Irritation
1
1
Cellulitis
1
1
Joint Laxity
1
1
Sepsis
1
1
Metal Related Pathology
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Exactech, Inc.
II
Oct-21-2019
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