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 passer, wire, orthopedic
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXI
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2021 2 2
2022 8 8
2023 12 17
2024 6 6
2025 3 3
2026 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 13 13
Fracture 11 11
Detachment of Device or Device Component 5 5
Contamination /Decontamination Problem 4 4
Packaging Problem 3 3
Patient Device Interaction Problem 2 2
Mechanical Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Defective Device 1 1
Material Fragmentation 1 1
Unsealed Device Packaging 1 1
Insufficient Device Problem Information 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Foreign Body In Patient 12 12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Insufficient Information 4 4
Blister 3 8
Rash 3 8
Rheumatoid Arthritis 1 6
Hypersensitivity/Allergic reaction 1 6
Inflammation 1 6
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Paragon 28, Inc. II Jul-17-2026
-
-