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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor
Product CodeGAD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 62 62
2020 86 86
2021 81 81
2022 80 80
2023 80 80
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 143 143
Device-Device Incompatibility 45 45
Crack 38 38
Detachment of Device or Device Component 33 33
Material Integrity Problem 26 26
Compatibility Problem 25 25
Material Twisted/Bent 15 15
Mechanical Jam 13 13
Adverse Event Without Identified Device or Use Problem 12 12
Fracture 12 12
Material Deformation 10 10
Mechanical Problem 9 9
Difficult to Remove 9 9
Component Missing 7 7
Contamination /Decontamination Problem 5 5
Mechanics Altered 5 5
Patient Device Interaction Problem 4 4
Device Slipped 4 4
Material Fragmentation 4 4
Material Separation 3 3
Use of Device Problem 3 3
Device Dislodged or Dislocated 3 3
Difficult to Open or Close 2 2
Difficult to Insert 2 2
Entrapment of Device 2 2
Positioning Failure 2 2
Material Split, Cut or Torn 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Device Difficult to Maintain 2 2
Positioning Problem 2 2
Scratched Material 2 2
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Excessive Heating 2 2
Separation Problem 1 1
Device Handling Problem 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Naturally Worn 1 1
No Apparent Adverse Event 1 1
Sharp Edges 1 1
Device Fell 1 1
Material Discolored 1 1
Material Erosion 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
No Device Output 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Fail-Safe Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 248 248
No Consequences Or Impact To Patient 60 60
No Patient Involvement 24 24
No Known Impact Or Consequence To Patient 19 19
Insufficient Information 17 17
Foreign Body In Patient 13 13
No Information 7 7
Device Embedded In Tissue or Plaque 7 7
No Code Available 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Bone Fracture(s) 5 5
Cancer 4 4
Liver Damage/Dysfunction 3 3
Pain 3 3
Burn, Thermal 2 2
Hemorrhage/Bleeding 2 2
Perforation of Vessels 2 2
Superficial (First Degree) Burn 1 1
Unspecified Heart Problem 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Unintended Radiation Exposure 1 1
Not Applicable 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Necrosis 1 1
Granuloma 1 1
Wound Dehiscence 1 1
Death 1 1
Exsanguination 1 1
Blood Loss 1 1
Tissue Damage 1 1
Injury 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Numbness 1 1
Spinal Cord Injury 1 1
Post Operative Wound Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag II Apr-06-2020
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
3 Medagent Inc II Feb-23-2024
4 Medtronic Navigation, Inc. II Jan-12-2023
5 Smith & Nephew, Inc. II Aug-17-2020
6 TELEFLEX LLC II Jul-05-2023
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