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TPLC
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show TPLC since
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2024
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Device
component, external, limb, ankle/foot
Product Code
ISH
Regulation Number
890.3420
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
4
4
2015
4
4
2016
9
9
2017
6
6
2018
7
7
2019
4
4
2020
5
5
2021
3
3
2022
2
2
2023
21
21
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Naturally Worn
18
18
Fracture
12
12
Break
11
11
Insufficient Information
5
5
Product Quality Problem
3
3
Device Slipped
3
3
Patient-Device Incompatibility
2
2
Detachment of Device or Device Component
2
2
Detachment Of Device Component
2
2
Component Incompatible
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
1
1
Migration
1
1
Physical Resistance/Sticking
1
1
Misassembled During Installation
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Unintended Movement
1
1
Crack
1
1
Unintended Ejection
1
1
Component Falling
1
1
Mechanical Problem
1
1
Migration or Expulsion of Device
1
1
Unintended System Motion
1
1
Device Operates Differently Than Expected
1
1
Device-Device Incompatibility
1
1
Mechanics Altered
1
1
Improper or Incorrect Procedure or Method
1
1
Fitting Problem
1
1
Component Missing
1
1
Defective Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Fall
18
18
No Clinical Signs, Symptoms or Conditions
13
13
No Consequences Or Impact To Patient
11
11
Pain
7
7
Injury
6
6
Tissue Damage
4
4
No Known Impact Or Consequence To Patient
3
3
Hip Fracture
2
2
Failure of Implant
2
2
Joint Dislocation
2
2
Limb Fracture
2
2
Impaired Healing
2
2
Bone Fracture(s)
2
2
Unspecified Tissue Injury
2
2
Bruise/Contusion
2
2
No Information
1
1
Hemorrhage/Bleeding
1
1
Low Oxygen Saturation
1
1
Loss of consciousness
1
1
Discomfort
1
1
Depression
1
1
Unspecified Infection
1
1
Blister
1
1
Vertebral Fracture
1
1
Head Injury
1
1
Osteopenia/ Osteoporosis
1
1
Insufficient Information
1
1
Fracture, Arm
1
1
Skin Irritation
1
1
Pressure Sores
1
1
Ambulation Difficulties
1
1
Subluxation
1
1
Irritability
1
1
Arthralgia
1
1
Swelling
1
1
Laceration(s)
1
1
Tooth Fracture
1
1
Reaction
1
1
Optical Tissue, Breakdown Of
1
1
Concussion
1
1
Fatigue
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
College Park Industries, Inc.
II
May-23-2012
2
Ossur Americas
II
Jul-05-2022
3
Ossur Americas, Inc.
II
Feb-06-2014
4
Ossur H / F
II
Jun-13-2023
5
Ossur H / F
II
Mar-17-2015
6
Ossur North America Inc
II
Nov-19-2013
7
Otto Bock Healthcare GmbH
II
Nov-04-2015
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