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TPLC
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show TPLC since
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Device
rongeur
Product Code
HTX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
38
38
2016
28
28
2017
26
26
2018
25
25
2019
24
24
2020
29
29
2021
26
26
2022
23
23
2023
14
14
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
138
138
Fracture
25
25
Material Fragmentation
21
21
Detachment Of Device Component
13
13
Detachment of Device or Device Component
9
9
Component Missing
9
9
Contamination /Decontamination Problem
6
6
Material Integrity Problem
6
6
Material Separation
6
6
Material Deformation
5
5
Component Falling
5
5
Appropriate Term/Code Not Available
5
5
Device Fell
4
4
Material Twisted/Bent
4
4
Bent
4
4
Material Erosion
4
4
Loose or Intermittent Connection
4
4
Mechanical Problem
4
4
Peeled/Delaminated
4
4
Insufficient Information
3
3
Missing Value Reason
3
3
Device Operates Differently Than Expected
3
3
Compatibility Problem
3
3
Device Dislodged or Dislocated
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Difficult to Remove
2
2
Device Or Device Fragments Location Unknown
2
2
Entrapment of Device
2
2
Device Slipped
1
1
Material Torqued
1
1
Corroded
1
1
Unstable
1
1
Material Discolored
1
1
Solder Joint Fracture
1
1
Device Inoperable
1
1
Delivered as Unsterile Product
1
1
Difficult to Open or Close
1
1
Structural Problem
1
1
Failure to Cut
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
89
89
No Clinical Signs, Symptoms or Conditions
59
59
No Consequences Or Impact To Patient
27
27
Foreign Body In Patient
24
24
No Patient Involvement
16
16
Insufficient Information
16
16
Device Embedded In Tissue or Plaque
12
12
No Information
7
7
No Code Available
7
7
Hemorrhage/Bleeding
3
3
Pain
2
2
Missing Value Reason
2
2
Patient Problem/Medical Problem
2
2
Unspecified Tissue Injury
1
1
Atrial Fibrillation
1
1
Failure of Implant
1
1
Nerve Damage
1
1
Injury
1
1
Deformity/ Disfigurement
1
1
Spinal Cord Injury
1
1
Ambulation Difficulties
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Exactech, Inc.
II
Jul-03-2017
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