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TPLC
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show TPLC since
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Device
driver, prosthesis
Product Code
HWR
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
738
738
2021
898
898
2022
980
980
2023
1281
1281
2024
1212
1212
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
2392
2392
Material Twisted/Bent
1474
1474
Device-Device Incompatibility
674
674
Naturally Worn
355
355
Material Deformation
211
211
Crack
191
191
Entrapment of Device
93
93
Fracture
73
73
Mechanical Problem
73
73
Material Integrity Problem
73
73
Mechanical Jam
69
69
Contamination /Decontamination Problem
40
40
Failure to Cut
26
26
Unintended Movement
26
26
No Apparent Adverse Event
22
22
Detachment of Device or Device Component
21
21
Adverse Event Without Identified Device or Use Problem
19
19
Appropriate Term/Code Not Available
16
16
Scratched Material
12
12
Device Slipped
12
12
Component Missing
11
11
Structural Problem
11
11
Corroded
9
9
Physical Resistance/Sticking
7
7
Calibration Problem
7
7
Use of Device Problem
5
5
Material Split, Cut or Torn
4
4
Illegible Information
3
3
Loose or Intermittent Connection
3
3
Improper or Incorrect Procedure or Method
3
3
Defective Device
2
2
Defective Component
2
2
Material Fragmentation
2
2
Material Discolored
2
2
Flaked
2
2
Device Fell
1
1
Difficult to Remove
1
1
Difficult to Insert
1
1
Moisture or Humidity Problem
1
1
Off-Label Use
1
1
Material Separation
1
1
Device Reprocessing Problem
1
1
Connection Problem
1
1
Compatibility Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4080
4080
No Consequences Or Impact To Patient
554
554
Insufficient Information
416
416
No Code Available
86
86
Foreign Body In Patient
59
59
No Patient Involvement
31
31
Not Applicable
6
6
No Information
6
6
No Known Impact Or Consequence To Patient
4
4
Injury
4
4
Limb Fracture
4
4
Pain
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Neuropathy
1
1
Unspecified Infection
1
1
Failure of Implant
1
1
Bone Fracture(s)
1
1
Foreign Body Reaction
1
1
Burn(s)
1
1
Nerve Damage
1
1
Device Embedded In Tissue or Plaque
1
1
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