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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 13 13
Break 11 11
Fracture 5 5
Product Quality Problem 3 3
Residue After Decontamination 3 3
Material Integrity Problem 2 2
Physical Resistance/Sticking 2 2
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
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical 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 Fell 1 1
Defective 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 17 17
No Known Impact Or Consequence To Patient 12 12
No Consequences Or Impact To Patient 7 7
No Patient Involvement 5 5
Foreign Body In Patient 4 4
Device Embedded In Tissue or Plaque 4 4
Insufficient Information 3 3
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-13-2022
2 ArthroCare Corporation II Sep-22-2020
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