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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device retractor
Regulation Description Manual surgical instrument for general use.
Product CodeGAD
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2020 86 86
2021 81 81
2022 80 80
2023 80 80
2024 111 111
2025 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Break 168 168
Device-Device Incompatibility 42 42
Crack 42 42
Detachment of Device or Device Component 36 36
Material Integrity Problem 35 35
Compatibility Problem 31 31
Material Twisted/Bent 21 21
Fracture 16 16
Material Deformation 14 14
Adverse Event Without Identified Device or Use Problem 14 14
Mechanical Jam 13 13
Mechanical Problem 13 13
Contamination /Decontamination Problem 10 10
Corroded 8 8
Difficult to Remove 8 8
Scratched Material 8 8
Material Fragmentation 7 7
Mechanics Altered 7 7
Component Missing 6 6
Material Separation 4 4
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 3 3
Entrapment of Device 3 3
Device Dislodged or Dislocated 3 3
Positioning Problem 3 3
Use of Device Problem 3 3
Difficult to Open or Close 2 2
Excessive Heating 2 2
Appropriate Term/Code Not Available 2 2
Positioning Failure 2 2
Difficult to Insert 2 2
Insufficient Information 2 2
Unintended Movement 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Failure to Power Up 1 1
Problem with Sterilization 1 1
Fail-Safe Problem 1 1
Sharp Edges 1 1
Defective Device 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Migration 1 1
Material Erosion 1 1
Failure to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 337 337
Insufficient Information 36 36
No Consequences Or Impact To Patient 33 33
Foreign Body In Patient 12 12
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 10 10
Device Embedded In Tissue or Plaque 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Bone Fracture(s) 5 5
Cancer 4 4
No Code Available 4 4
Laceration(s) 4 4
Liver Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Perforation of Vessels 3 3
Pain 3 3
Necrosis 2 2
Abdominal Pain 2 2
Unintended Radiation Exposure 2 2
Blood Loss 1 1
Blister 1 1
Post Operative Wound Infection 1 1
Burn, Thermal 1 1
Fever 1 1
Hematoma 1 1
Diarrhea 1 1
Vomiting 1 1
Osteolysis 1 1
Numbness 1 1
Exsanguination 1 1
No Information 1 1
Nausea 1 1
Muscle/Tendon Damage 1 1
Failure of Implant 1 1
Unspecified Tissue Injury 1 1
Unspecified Heart Problem 1 1
Joint Dislocation 1 1
Liver Damage/Dysfunction 1 1
Wound Dehiscence 1 1
Granuloma 1 1
Spinal Cord Injury 1 1
Superficial (First Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag II Apr-06-2020
2 MEDLINE INDUSTRIES, LP - Northfield II May-15-2025
3 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
4 Medagent Inc II Feb-23-2024
5 Medtronic Navigation, Inc. II Jan-12-2023
6 SEASPINE ORTHOPEDICS CORPORATION II Jun-28-2024
7 Sklar Instruments II Jan-16-2025
8 Smith & Nephew, Inc. II Aug-17-2020
9 TELEFLEX LLC II Jul-05-2023
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