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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
2019
11
11
2020
12
12
2021
11
11
2022
8
8
2023
12
12
2024
5
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Material Fragmentation
20
20
Break
13
13
Product Quality Problem
3
3
Fracture
3
3
Physical Resistance/Sticking
2
2
Material Integrity Problem
2
2
Device Dislodged or Dislocated
2
2
Corroded
2
2
Loose or Intermittent Connection
2
2
Entrapment of Device
1
1
Mechanical Problem
1
1
Crack
1
1
Device Fell
1
1
Defective Device
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Contamination /Decontamination Problem
1
1
Material Too Rigid or Stiff
1
1
Component Missing
1
1
Problem with Sterilization
1
1
Solder Joint Fracture
1
1
Material Separation
1
1
Detachment of Device or Device Component
1
1
Device Contamination with Chemical or Other Material
1
1
Nonstandard Device
1
1
Deformation Due to Compressive Stress
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
30
30
Foreign Body In Patient
8
8
No Known Impact Or Consequence To Patient
6
6
Insufficient Information
6
6
No Consequences Or Impact To Patient
6
6
No Patient Involvement
3
3
Patient Problem/Medical Problem
2
2
Device Embedded In Tissue or Plaque
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Code Available
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
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