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TPLC
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Device
system, isokinetic testing and evaluation
Product Code
IKK
Regulation Number
890.1925
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
2
2
2020
1
1
2021
1
1
2022
3
3
2023
4
4
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Melted
2
2
Break
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Patient Device Interaction Problem
1
1
Degraded
1
1
Mechanical Problem
1
1
Unintended System Motion
1
1
Smoking
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4
4
Bone Fracture(s)
2
2
No Consequences Or Impact To Patient
2
2
Discomfort
1
1
Impaired Healing
1
1
Limb Fracture
1
1
Hyperextension
1
1
Joint Laxity
1
1
Muscle/Tendon Damage
1
1
Unspecified Tissue Injury
1
1
Hematoma
1
1
Pain
1
1
Skin Discoloration
1
1
Edema
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hocoma AG
II
Jun-23-2020
2
Trexo Robotics Holdings Inc.
II
Jul-25-2023
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