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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
2021 81 81
2022 80 81
2023 80 80
2024 111 111
2025 107 107

Device Problems MDRs with this Device Problem Events in those MDRs
Break 190 191
Crack 43 43
Material Integrity Problem 35 35
Device-Device Incompatibility 34 34
Detachment of Device or Device Component 32 32
Compatibility Problem 30 30
Material Twisted/Bent 18 18
Material Deformation 13 13
Fracture 12 12
Adverse Event Without Identified Device or Use Problem 11 11
Corroded 9 9
Mechanical Problem 8 8
Contamination /Decontamination Problem 8 8
Mechanics Altered 7 7
Scratched Material 7 7
Mechanical Jam 6 6
Material Fragmentation 6 6
Difficult to Remove 5 5
Insufficient Information 4 4
Patient Device Interaction Problem 4 4
Use of Device Problem 4 4
Component Missing 4 4
Material Separation 3 3
Device Dislodged or Dislocated 3 3
Positioning Problem 2 2
Unintended Movement 2 2
Positioning Failure 2 2
Physical Resistance/Sticking 2 2
Retraction Problem 2 2
Entrapment of Device 2 2
Excessive Heating 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Contamination 1 1
Defective Device 1 1
Difficult to Insert 1 1
Fail-Safe Problem 1 1
Separation Failure 1 1
Problem with Sterilization 1 1
Device Damaged by Another Device 1 1
Device Damaged Prior to Use 1 1
Sharp Edges 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Handling Problem 1 1
Product Quality Problem 1 1
Off-Label Use 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Migration 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 375 376
Insufficient Information 34 34
Foreign Body In Patient 10 10
Bone Fracture(s) 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Device Embedded In Tissue or Plaque 5 5
Laceration(s) 4 4
Cancer 4 4
Perforation of Vessels 3 3
Hemorrhage/Bleeding 3 3
Liver Laceration(s) 3 3
Abdominal Pain 2 2
Pain 2 2
Unintended Radiation Exposure 2 2
Superficial (First Degree) Burn 1 1
Wound Dehiscence 1 1
Liver Damage/Dysfunction 1 1
Joint Dislocation 1 1
Failure of Implant 1 1
Nausea 1 1
Necrosis 1 1
Hematoma 1 1
Blister 1 1
Post Operative Wound Infection 1 1
Burn(s) 1 1
Fever 1 1
Diarrhea 1 1
Vomiting 1 1
Osteolysis 1 1
Numbness 1 1
No Patient Involvement 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1
Unspecified Heart Problem 1 1
No Consequences Or Impact To Patient 1 1
Spinal Cord Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II May-15-2025
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 SEASPINE ORTHOPEDICS CORPORATION II Jun-28-2024
6 Sklar Instruments II Jan-16-2025
7 TELEFLEX LLC II Jul-05-2023
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