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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
2026 44 44

Device Problems MDRs with this Device Problem Events in those MDRs
Break 192 193
Crack 43 43
Device-Device Incompatibility 39 39
Material Integrity Problem 36 36
Detachment of Device or Device Component 33 33
Compatibility Problem 30 30
Adverse Event Without Identified Device or Use Problem 20 20
Material Twisted/Bent 17 17
Material Deformation 13 13
Fracture 13 13
Mechanical Problem 12 12
Contamination /Decontamination Problem 9 9
Mechanical Jam 8 8
Corroded 7 7
Scratched Material 7 7
Mechanics Altered 7 7
Difficult to Remove 5 5
Material Fragmentation 4 4
Insufficient Device Problem Information 4 4
Patient Device Interaction Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Entrapment of Device 3 3
Material Separation 3 3
Device Dislodged or Dislocated 2 2
Positioning Problem 2 2
Use of Device Problem 2 2
Excessive Heating 2 2
Component Missing 2 2
Positioning Failure 2 2
Fitting Problem 2 2
Product Quality Problem 1 1
Noise, Audible 1 1
Material Split, Cut or Torn 1 1
Separation Failure 1 1
Unstable 1 1
Difficult to Insert 1 1
Contamination 1 1
Physical Resistance/Sticking 1 1
Naturally Worn 1 1
Off-Label Use 1 1
Device Damaged Prior to Use 1 1
Unintended Movement 1 1
Overheating of Device 1 1
Device Handling Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Protrusion/Extrusion 1 1
Device Damaged by Another Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 404 405
Insufficient Information 36 36
Foreign Body In Patient 14 14
Hemorrhage/Blood Loss/Bleeding 6 6
Bone Fracture(s) 6 6
Device Embedded In Tissue or Plaque 5 5
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 5 5
Laceration(s) 4 4
Cancer 4 4
Bowel Perforation 4 4
Perforation of Vessels 3 3
Liver Laceration(s) 3 3
Hematoma 2 2
Unintended Radiation Exposure 2 2
Nerve Damage 2 2
Abdominal Pain 2 2
Pain 2 2
Unspecified Tissue Injury 2 2
Liver Damage/Dysfunction 1 1
No Patient Involvement 1 1
Numbness 1 1
Spinal Cord Injury 1 1
Osteolysis 1 1
No Consequences Or Impact To Patient 1 1
Vomiting 1 1
Nausea 1 1
High White Blood Cell Count 1 1
Post Operative Wound Infection 1 1
Wound Dehiscence 1 1
Burn(s) 1 1
Unspecified Heart Problem 1 1
Superficial (First Degree) Burn 1 1
Blister 1 1
Failure of Implant 1 1
Necrosis 1 1
Joint Dislocation 1 1
Fever 1 1
Muscle/Tendon Damage 1 1
Diarrhea 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. (NeuroSciences) II Jul-09-2026
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 TELEFLEX LLC II Jul-05-2023
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