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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device holder, needle; orthopedic
Product CodeHXK
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Break 25 25
Material Fragmentation 21 21
Fracture 7 7
Product Quality Problem 3 3
Residue After Decontamination 3 3
Material Integrity Problem 3 3
Detachment of Device or Device Component 2 2
Physical Resistance/Sticking 2 2
Device Operational Issue 2 2
Loose or Intermittent Connection 2 2
Corroded 2 2
Solder Joint Fracture 2 2
Device Dislodged or Dislocated 2 2
Problem with Sterilization 1 1
Device Contamination with Chemical or Other Material 1 1
Material Separation 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Deformation Due to Compressive Stress 1 1
Crack 1 1
Insufficient Information 1 1
Device Fell 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Disassembly 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Material Too Rigid or Stiff 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 30 30
No Known Impact Or Consequence To Patient 20 20
No Consequences Or Impact To Patient 9 9
Foreign Body In Patient 8 8
Insufficient Information 6 6
Device Embedded In Tissue or Plaque 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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