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TPLC
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show TPLC since
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Device
joint, knee, external limb component
Product Code
ISY
Regulation Number
890.3420
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
22
22
2020
80
80
2021
35
35
2022
23
23
2023
24
24
2024
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
92
92
Unintended System Motion
43
43
Device Handling Problem
23
23
Insufficient Information
15
15
Physical Resistance/Sticking
12
12
Adverse Event Without Identified Device or Use Problem
12
12
Fracture
2
2
Leak/Splash
1
1
Crack
1
1
Device Fell
1
1
Contamination /Decontamination Problem
1
1
Patient Device Interaction Problem
1
1
Misassembled During Installation
1
1
Component Missing
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Material Deformation
1
1
Detachment of Device or Device Component
1
1
Electromagnetic Interference
1
1
Fungus in Device Environment
1
1
Improper or Incorrect Procedure or Method
1
1
Deformation Due to Compressive Stress
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
97
97
No Consequences Or Impact To Patient
38
38
No Clinical Signs, Symptoms or Conditions
35
35
Bone Fracture(s)
28
28
Limb Fracture
28
28
No Known Impact Or Consequence To Patient
24
24
Hip Fracture
11
11
Insufficient Information
8
8
Fracture, Arm
7
7
Injury
7
7
Laceration(s)
7
7
Bruise/Contusion
7
7
Damage to Ligament(s)
5
5
Concussion
4
4
Contusion
3
3
Spinal Column Injury
3
3
Pain
3
3
Head Injury
2
2
Multiple Fractures
2
2
Tissue Breakdown
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
1
1
Hematoma
1
1
No Patient Involvement
1
1
Muscle/Tendon Damage
1
1
Intervertebral Disc Compression or Protrusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ottobock Orthopedic Industrie
II
Feb-13-2019
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