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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
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
Material Fragmentation 20 20
Break 15 15
Fracture 7 7
Residue After Decontamination 3 3
Product Quality Problem 3 3
Corroded 2 2
Solder Joint Fracture 2 2
Loose or Intermittent Connection 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
Device Fell 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
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

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 12 12
No Consequences Or Impact To Patient 7 7
Foreign Body In Patient 7 7
Insufficient Information 6 6
No Patient Involvement 5 5
Device Embedded In Tissue or Plaque 4 4
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not 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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