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TPLC
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show TPLC since
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Device
component, traction, invasive
Product Code
JEC
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
ANJON HOLDINGS LLC
SUBSTANTIALLY EQUIVALENT
1
ANJON HOLDINGS, LLC
SUBSTANTIALLY EQUIVALENT
1
ARBUTUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
HAND BIOMECHANICS LAB, INC.
SUBSTANTIALLY EQUIVALENT
1
VIRAK ORTHOPEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
12
12
2018
2
2
2019
3
3
2020
6
6
2021
2
2
2022
3
3
2023
26
26
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
25
25
Break
7
7
Unintended Movement
5
5
Adverse Event Without Identified Device or Use Problem
4
4
Patient Device Interaction Problem
3
3
Detachment of Device or Device Component
3
3
Mechanical Jam
2
2
Material Twisted/Bent
1
1
Migration
1
1
Physical Resistance/Sticking
1
1
Contamination
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Device Slipped
1
1
Defective Component
1
1
Malposition of Device
1
1
Patient-Device Incompatibility
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
30
30
No Code Available
4
4
Injury
4
4
Bacterial Infection
3
3
Failure of Implant
3
3
No Patient Involvement
3
3
No Known Impact Or Consequence To Patient
2
2
No Consequences Or Impact To Patient
2
2
No Information
1
1
Malunion of Bone
1
1
Unspecified Tissue Injury
1
1
Insufficient Information
1
1
Unspecified Infection
1
1
Internal Organ Perforation
1
1
Pain
1
1
Burning Sensation
1
1
Death
1
1
Numbness
1
1
Pseudoaneurysm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Anjon Holdings
II
Aug-10-2020
2
Ossur Americas
II
Mar-11-2019
3
Stryker GmbH
II
Jan-07-2020
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