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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 96 96

Device Problems MDRs with this Device Problem Events in those MDRs
Break 165 165
Device-Device Incompatibility 46 46
Crack 41 41
Detachment of Device or Device Component 38 38
Material Integrity Problem 34 34
Compatibility Problem 29 29
Material Twisted/Bent 18 18
Adverse Event Without Identified Device or Use Problem 16 16
Mechanical Jam 13 13
Fracture 12 12
Material Deformation 11 11
Mechanical Problem 10 10
Contamination /Decontamination Problem 10 10
Difficult to Remove 9 9
Corroded 8 8
Mechanics Altered 7 7
Component Missing 7 7
Material Fragmentation 5 5
Device Slipped 4 4
Patient Device Interaction Problem 4 4
Material Separation 3 3
Use of Device Problem 3 3
Scratched Material 3 3
Device Dislodged or Dislocated 3 3
Positioning Problem 3 3
Insufficient Information 3 3
Entrapment of Device 3 3
Material Split, Cut or Torn 3 3
Appropriate Term/Code Not Available 2 2
Excessive Heating 2 2
Difficult to Insert 2 2
Positioning Failure 2 2
Difficult to Open or Close 2 2
Physical Resistance/Sticking 2 2
Device Difficult to Maintain 2 2
Fitting Problem 2 2
Failure to Advance 1 1
Connection Problem 1 1
Naturally Worn 1 1
No Apparent Adverse Event 1 1
Material Protrusion/Extrusion 1 1
Tear, Rip or Hole in Device Packaging 1 1
Improper or Incorrect Procedure or Method 1 1
No Device Output 1 1
Temperature Problem 1 1
Retraction Problem 1 1
Product Quality Problem 1 1
Device Handling Problem 1 1
Sharp Edges 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 297 297
No Consequences Or Impact To Patient 60 60
Insufficient Information 24 24
No Patient Involvement 24 24
No Known Impact Or Consequence To Patient 19 19
Foreign Body In Patient 13 13
Device Embedded In Tissue or Plaque 7 7
No Information 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
No Code Available 6 6
Bone Fracture(s) 5 5
Cancer 4 4
Liver Damage/Dysfunction 4 4
Liver Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Perforation of Vessels 3 3
Pain 3 3
Unintended Radiation Exposure 2 2
Laceration(s) 2 2
Burn, Thermal 2 2
Necrosis 2 2
Abdominal Pain 2 2
Blister 1 1
Post Operative Wound Infection 1 1
Blood Loss 1 1
Fever 1 1
Injury 1 1
Diarrhea 1 1
Vomiting 1 1
Osteolysis 1 1
Numbness 1 1
Hematoma 1 1
Exsanguination 1 1
Not Applicable 1 1
Muscle/Tendon Damage 1 1
Nausea 1 1
Unspecified Tissue Injury 1 1
Tissue Damage 1 1
Unspecified Heart Problem 1 1
Failure of Implant 1 1
Joint Dislocation 1 1
Death 1 1
Granuloma 1 1
Spinal Cord Injury 1 1
Wound Dehiscence 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 Smith & Nephew, Inc. II Aug-17-2020
7 TELEFLEX LLC II Jul-05-2023
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