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TPLC
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show TPLC since
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Device
joint, knee, external brace
Product Code
ITQ
Regulation Number
890.3475
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
12
12
2019
76
76
2020
22
22
2021
4
4
2022
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
78
78
Patient Device Interaction Problem
9
9
Break
6
6
Detachment of Device or Device Component
3
3
No Apparent Adverse Event
3
3
Insufficient Information
2
2
Collapse
2
2
Material Twisted/Bent
2
2
Inadequacy of Device Shape and/or Size
2
2
Physical Resistance/Sticking
2
2
Device Fell
1
1
Unexpected Therapeutic Results
1
1
Unstable
1
1
Material Integrity Problem
1
1
Unintended Movement
1
1
Mechanical Jam
1
1
Component Incompatible
1
1
Fracture
1
1
Patient-Device Incompatibility
1
1
Device Operates Differently Than Expected
1
1
Crack
1
1
Mechanical Problem
1
1
Device Slipped
1
1
Use of Device Problem
1
1
Defective Device
1
1
Loose or Intermittent Connection
1
1
Contamination /Decontamination Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Damage to Ligament(s)
64
64
Injury
13
13
No Consequences Or Impact To Patient
5
5
Fall
5
5
Tissue Damage
4
4
Patient Problem/Medical Problem
3
3
Bone Fracture(s)
3
3
No Known Impact Or Consequence To Patient
3
3
Insufficient Information
3
3
Joint Dislocation
2
2
Swelling
2
2
Thrombosis
1
1
Convulsion, Tonic
1
1
Thrombosis/Thrombus
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Hematoma
1
1
Hypersensitivity/Allergic reaction
1
1
Inflammation
1
1
Unspecified Tissue Injury
1
1
Convulsion, Clonic
1
1
Bruise/Contusion
1
1
Edema
1
1
Ambulation Difficulties
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Hip Fracture
1
1
Neuropathy
1
1
Rash
1
1
Sprain
1
1
Laceration(s)
1
1
Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DeRoyal Industries Inc
II
Dec-19-2019
2
Mueller Sports Medicine, Inc
II
Jun-30-2020
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