Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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
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
Mechanical Problem 1 1
Entrapment of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Component Missing 1 1
Material Too Rigid or Stiff 1 1
Problem with Sterilization 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Device Contamination with Chemical or Other Material 1 1
Crack 1 1
Device Fell 1 1
Solder Joint Fracture 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
-
-