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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
2020 86 86
2021 81 81
2022 80 80
2023 80 80
2024 111 111

Device Problems MDRs with this Device Problem Events in those MDRs
Break 145 145
Device-Device Incompatibility 42 42
Crack 39 39
Detachment of Device or Device Component 35 35
Material Integrity Problem 34 34
Compatibility Problem 29 29
Material Twisted/Bent 20 20
Adverse Event Without Identified Device or Use Problem 14 14
Mechanical Jam 13 13
Fracture 12 12
Mechanical Problem 11 11
Contamination /Decontamination Problem 10 10
Corroded 8 8
Material Deformation 8 8
Difficult to Remove 8 8
Scratched Material 8 8
Mechanics Altered 7 7
Component Missing 6 6
Material Fragmentation 5 5
Patient Device Interaction Problem 4 4
Material Split, Cut or Torn 3 3
Entrapment of Device 3 3
Device Dislodged or Dislocated 3 3
Material Separation 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
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
Insufficient Information 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unintended Movement 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Material Erosion 1 1
Failure to Advance 1 1
Difficult to Open or Remove Packaging Material 1 1
Off-Label Use 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 309 309
No Consequences Or Impact To Patient 33 33
Insufficient Information 27 27
Foreign Body In Patient 12 12
No Patient Involvement 11 11
No Known Impact Or Consequence To Patient 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Device Embedded In Tissue or Plaque 5 5
Bone Fracture(s) 5 5
No Code Available 4 4
Cancer 4 4
Liver Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Perforation of Vessels 3 3
Pain 3 3
Abdominal Pain 2 2
Unintended Radiation Exposure 2 2
Necrosis 2 2
Laceration(s) 2 2
Spinal Cord Injury 1 1
Granuloma 1 1
Unspecified Heart Problem 1 1
Unspecified Tissue Injury 1 1
Muscle/Tendon Damage 1 1
Vomiting 1 1
Diarrhea 1 1
Numbness 1 1
Osteolysis 1 1
Fever 1 1
Post Operative Wound Infection 1 1
Blister 1 1
Blood Loss 1 1
Burn, Thermal 1 1
Hematoma 1 1
Exsanguination 1 1
No Information 1 1
Nausea 1 1
Failure of Implant 1 1
Liver Damage/Dysfunction 1 1
Wound Dehiscence 1 1
Joint Dislocation 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 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 Smith & Nephew, Inc. II Aug-17-2020
8 TELEFLEX LLC II Jul-05-2023
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