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TPLC
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show TPLC since
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2024
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Device
holder, needle; orthopedic
Product Code
HXK
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
6
6
2016
6
6
2017
5
5
2018
7
7
2019
11
11
2020
12
12
2021
11
11
2022
8
8
2023
12
12
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
24
24
Material Fragmentation
20
20
Fracture
7
7
Residue After Decontamination
3
3
Product Quality Problem
3
3
Material Integrity Problem
3
3
Physical Resistance/Sticking
2
2
Detachment of Device or Device Component
2
2
Device Operational Issue
2
2
Device Dislodged or Dislocated
2
2
Corroded
2
2
Solder Joint Fracture
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
1
1
Defective Device
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Crack
1
1
Disassembly
1
1
Entrapment of Device
1
1
Material Too Rigid or Stiff
1
1
Material Separation
1
1
Problem with Sterilization
1
1
Component Missing
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Fell
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
27
27
No Known Impact Or Consequence To Patient
20
20
No Consequences Or Impact To Patient
9
9
Foreign Body In Patient
7
7
Device Embedded In Tissue or Plaque
6
6
Insufficient Information
6
6
No Patient Involvement
5
5
Patient Problem/Medical Problem
2
2
No Code Available
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-14-2023
2
Aesculap Implant Systems LLC
II
Jul-13-2022
3
ArthroCare Corporation
II
Sep-22-2020
4
DePuy Orthopaedics, Inc.
II
Jan-11-2012
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