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 hook, surgical, general & plastic surgery
Product CodeGDG
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 9 9
2021 18 18
2022 11 11
2023 6 6
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 26 26
Fracture 10 10
Material Fragmentation 7 7
Entrapment of Device 4 4
Device Slipped 2 2
Material Integrity Problem 2 2
Compatibility Problem 1 1
Material Split, Cut or Torn 1 1
Device-Device Incompatibility 1 1
Device Fell 1 1
Positioning Problem 1 1
Component Missing 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Difficult to Remove 1 1
Migration or Expulsion of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 23 23
Foreign Body In Patient 11 11
Device Embedded In Tissue or Plaque 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 3 3
No Consequences Or Impact To Patient 3 3
No Patient Involvement 2 2
Patient Problem/Medical Problem 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
-
-