• 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 bit, surgical
Product CodeGFG
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 52 52
2021 68 68
2022 69 69
2023 52 52
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Break 147 147
Fracture 48 48
Material Fragmentation 19 19
Entrapment of Device 18 18
Failure to Cut 14 14
Material Separation 9 9
Device-Device Incompatibility 8 8
Mechanical Jam 8 8
Residue After Decontamination 5 5
Insufficient Information 3 3
Contamination /Decontamination Problem 3 3
Device Markings/Labelling Problem 3 3
Delivered as Unsterile Product 3 3
Firing Problem 2 2
Dull, Blunt 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Material Deformation 2 2
Material Integrity Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Inadequacy of Device Shape and/or Size 1 1
Use of Device Problem 1 1
Flaked 1 1
Mechanical Problem 1 1
Misassembled 1 1
Crack 1 1
Failure to Cycle 1 1
Material Discolored 1 1
Difficult to Open or Close 1 1
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Failure to Align 1 1
Failure to Fire 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Detachment of Device or Device Component 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 180 180
Foreign Body In Patient 30 30
Insufficient Information 25 25
No Consequences Or Impact To Patient 23 23
No Known Impact Or Consequence To Patient 11 11
No Information 11 11
Device Embedded In Tissue or Plaque 7 7
Injury 4 4
Not Applicable 3 3
No Patient Involvement 2 2
Metal Related Pathology 1 1
Spinal Cord Injury 1 1
Cerebrospinal Fluid Leakage 1 1
Failure of Implant 1 1
Perforation 1 1

-
-