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TPLC
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show TPLC since
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2024
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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
SINTEA BIOTECH, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORP.
SUBSTANTIALLY EQUIVALENT
1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
SUBSTANTIALLY EQUIVALENT
1
VIRAK ORTHOPEDIC RESEARCH, LLC
SUBSTANTIALLY EQUIVALENT
1
VIRAK ORTHOPEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
1
1
2016
8
8
2017
12
12
2018
2
2
2019
3
3
2020
6
6
2021
2
2
2022
3
3
2023
26
26
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
27
27
Break
13
13
Unintended Movement
5
5
Detachment of Device or Device Component
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Patient Device Interaction Problem
3
3
Mechanical Jam
3
3
Difficult to Advance
2
2
Positioning Problem
2
2
Difficult to Remove
2
2
Loose or Intermittent Connection
2
2
Crack
2
2
Migration or Expulsion of Device
2
2
Mechanical Problem
2
2
Patient-Device Incompatibility
1
1
Defective Component
1
1
Therapeutic or Diagnostic Output Failure
1
1
Contamination
1
1
Scratched Material
1
1
Material Fragmentation
1
1
Device Slipped
1
1
Device Maintenance Issue
1
1
Component Missing
1
1
Material Too Rigid or Stiff
1
1
Material Twisted/Bent
1
1
Migration
1
1
No Apparent Adverse Event
1
1
Difficult To Position
1
1
Physical Resistance/Sticking
1
1
Malposition of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
31
31
No Code Available
11
11
No Known Impact Or Consequence To Patient
6
6
Failure of Implant
5
5
Injury
5
5
No Patient Involvement
3
3
Bacterial Infection
3
3
Insufficient Information
2
2
No Consequences Or Impact To Patient
2
2
Unspecified Infection
1
1
Death
1
1
No Information
1
1
Bone Fracture(s)
1
1
Burning Sensation
1
1
Numbness
1
1
Pain
1
1
Malunion of Bone
1
1
Unspecified Tissue Injury
1
1
Pseudoaneurysm
1
1
Internal Organ Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Acumed LLC
II
Mar-16-2010
2
Anjon Holdings
II
Aug-10-2020
3
Hand Biomechanics Lab Inc
II
Oct-18-2016
4
Ossur Americas
II
Mar-11-2019
5
Stryker GmbH
II
Jan-07-2020
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