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TPLC
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show TPLC since
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Device
joint, knee, external limb component
Regulation Description
External limb prosthetic component.
Product Code
ISY
Regulation Number
890.3420
Device Class
1
MDR Year
MDR Reports
MDR Events
2016
49
49
2017
87
87
2018
34
34
2019
22
22
2020
80
80
2021
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
141
141
Device Operates Differently Than Expected
62
62
Device Handling Problem
39
39
Adverse Event Without Identified Device or Use Problem
20
20
Component Missing
4
4
Screw
4
4
Break
3
3
Insufficient Information
3
3
Loose or Intermittent Connection
3
3
Unintended System Motion
3
3
Failure To Service
2
2
Physical Resistance/Sticking
2
2
Fracture
2
2
Bolt
2
2
Heads
1
1
Bearings
1
1
Device Slipped
1
1
Stretched
1
1
Use of Device Problem
1
1
Crack
1
1
Deformation Due to Compressive Stress
1
1
Detachment of Device or Device Component
1
1
Human Factors Issue
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Thread
1
1
Patient Device Interaction Problem
1
1
Device Fell
1
1
Device Maintenance Issue
1
1
Improper or Incorrect Procedure or Method
1
1
Fungus in Device Environment
1
1
Contamination /Decontamination Problem
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Electrical /Electronic Property Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
123
123
Fall
63
63
Bone Fracture(s)
42
42
No Known Impact Or Consequence To Patient
29
29
Injury
18
18
Fracture, Arm
14
14
No Clinical Signs, Symptoms or Conditions
12
12
Hip Fracture
9
9
Bruise/Contusion
8
8
Concussion
8
8
Head Injury
7
7
Rupture
6
6
Laceration(s)
5
5
Damage to Ligament(s)
4
4
Spinal Column Injury
4
4
Contusion
3
3
Hematoma
3
3
Joint Dislocation
3
3
No Code Available
2
2
Limb Fracture
2
2
Pain
2
2
Skull Fracture
2
2
Abrasion
2
2
Death
1
1
Intracranial Hemorrhage
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Loss of consciousness
1
1
Tooth Fracture
1
1
Spinal Cord Injury
1
1
Neck Pain
1
1
No Patient Involvement
1
1
Arthralgia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Otto Bock Healthcare GmbH
II
Feb-01-2016
2
Otto Bock Healthcare Product
II
Mar-01-2018
3
Ottobock Orthopedic Industrie
II
Feb-13-2019
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