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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
2018
24
24
2019
24
24
2020
29
29
2021
26
26
2022
23
23
2023
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
64
64
Fracture
18
18
Material Fragmentation
10
10
Detachment of Device or Device Component
7
7
Material Integrity Problem
6
6
Material Separation
6
6
Peeled/Delaminated
4
4
Component Missing
4
4
Material Erosion
4
4
Contamination /Decontamination Problem
4
4
Device Fell
4
4
Material Twisted/Bent
3
3
Appropriate Term/Code Not Available
3
3
Compatibility Problem
3
3
Loose or Intermittent Connection
3
3
Mechanical Problem
3
3
Bent
2
2
Material Deformation
2
2
Device Operates Differently Than Expected
1
1
Device Dislodged or Dislocated
1
1
Entrapment of Device
1
1
Delivered as Unsterile Product
1
1
Solder Joint Fracture
1
1
Structural Problem
1
1
Failure to Cut
1
1
Difficult to Remove
1
1
Device Slipped
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
51
51
No Known Impact Or Consequence To Patient
30
30
No Consequences Or Impact To Patient
17
17
Insufficient Information
15
15
Foreign Body In Patient
12
12
No Patient Involvement
5
5
No Code Available
3
3
Patient Problem/Medical Problem
2
2
Device Embedded In Tissue or Plaque
2
2
No Information
2
2
Hemorrhage/Bleeding
2
2
Failure of Implant
1
1
Nerve Damage
1
1
Pain
1
1
Deformity/ Disfigurement
1
1
Spinal Cord Injury
1
1
Ambulation Difficulties
1
1
Unspecified Tissue Injury
1
1
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