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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 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Break 159 159
Device-Device Incompatibility 45 45
Crack 41 41
Detachment of Device or Device Component 36 36
Material Integrity Problem 30 30
Compatibility Problem 25 25
Material Twisted/Bent 17 17
Adverse Event Without Identified Device or Use Problem 16 16
Mechanical Jam 13 13
Fracture 12 12
Material Deformation 11 11
Contamination /Decontamination Problem 10 10
Mechanical Problem 9 9
Difficult to Remove 9 9
Corroded 7 7
Component Missing 7 7
Mechanics Altered 6 6
Device Slipped 4 4
Patient Device Interaction Problem 4 4
Material Fragmentation 4 4
Material Split, Cut or Torn 3 3
Entrapment of Device 3 3
Device Dislodged or Dislocated 3 3
Material Separation 3 3
Insufficient Information 3 3
Positioning Problem 3 3
Scratched Material 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
Device Difficult to Maintain 2 2
Positioning Failure 2 2
Difficult to Insert 2 2
Physical Resistance/Sticking 2 2
Fitting Problem 2 2
Fail-Safe Problem 1 1
Material Discolored 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Shipping Damage or Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Therapeutic or Diagnostic Output Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Defective Device 1 1
Sharp Edges 1 1
Device Fell 1 1
Device Handling Problem 1 1
Retraction Problem 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 278 278
No Consequences Or Impact To Patient 60 60
No Patient Involvement 24 24
Insufficient Information 22 22
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
Liver Damage/Dysfunction 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
Burn, Thermal 2 2
Laceration(s) 2 2
Spinal Cord Injury 1 1
Granuloma 1 1
Unspecified Heart Problem 1 1
Tissue Damage 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
Injury 1 1
Post Operative Wound Infection 1 1
Blister 1 1
Blood Loss 1 1
Hematoma 1 1
Exsanguination 1 1
Nausea 1 1
Failure of Implant 1 1
Not Applicable 1 1
Wound Dehiscence 1 1
Joint Dislocation 1 1
Death 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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