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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


Premarket Reviews
ManufacturerDecision
J.R. PARKER, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 78 78
2017 90 90
2018 77 77
2019 62 62
2020 86 86
2021 81 81
2022 80 80
2023 80 80
2024 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Break 233 233
Device-Device Incompatibility 47 47
Detachment of Device or Device Component 46 46
Crack 45 45
Adverse Event Without Identified Device or Use Problem 33 33
Fracture 29 29
Material Integrity Problem 27 27
Material Deformation 26 26
Compatibility Problem 25 25
Material Twisted/Bent 17 17
Detachment Of Device Component 16 16
Difficult to Remove 15 15
Mechanical Jam 14 14
Component Missing 13 13
Material Fragmentation 13 13
Mechanical Problem 11 11
Device Operates Differently Than Expected 11 11
Appropriate Term/Code Not Available 9 9
Disassembly 7 7
Device Slipped 6 6
Use of Device Problem 6 6
Fitting Problem 6 6
Contamination /Decontamination Problem 5 5
Insufficient Information 5 5
Positioning Problem 5 5
Mechanics Altered 5 5
Material Separation 5 5
Scratched Material 4 4
Difficult to Open or Close 4 4
Patient Device Interaction Problem 4 4
Physical Resistance/Sticking 3 3
Device Dislodged or Dislocated 3 3
Overheating of Device 3 3
Difficult or Delayed Positioning 3 3
Failure To Adhere Or Bond 3 3
Bent 3 3
Device Reprocessing Problem 2 2
Component Falling 2 2
Positioning Failure 2 2
Difficult to Insert 2 2
Entrapment of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Sticking 2 2
Product Quality Problem 2 2
Temperature Problem 2 2
Unintended Movement 2 2
Device Difficult to Maintain 2 2
Naturally Worn 2 2
Excessive Heating 2 2
Material Split, Cut or Torn 2 2
Device Handling Problem 2 2
Separation Problem 1 1
Sharp Edges 1 1
Device Fell 1 1
Material Distortion 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Dull, Blunt 1 1
Failure to Align 1 1
Failure to Advance 1 1
Defective Device 1 1
Fail-Safe Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Markings/Labelling Problem 1 1
Device Inoperable 1 1
Shipping Damage or Problem 1 1
Smoking 1 1
Material Erosion 1 1
No Device Output 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Material Discolored 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 249 249
No Known Impact Or Consequence To Patient 107 107
No Consequences Or Impact To Patient 104 104
No Patient Involvement 62 62
No Information 26 26
Foreign Body In Patient 18 18
Device Embedded In Tissue or Plaque 17 17
Insufficient Information 17 17
No Code Available 16 16
Injury 9 9
Hemorrhage/Bleeding 6 6
Bone Fracture(s) 5 5
Pain 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cancer 4 4
Burn, Thermal 4 4
Blood Loss 4 4
Hematoma 4 4
Tissue Damage 4 4
Burn(s) 4 4
Liver Damage/Dysfunction 3 3
Not Applicable 3 3
Skin Tears 3 3
Bowel Perforation 2 2
Superficial (First Degree) Burn 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Necrosis 2 2
Swelling 2 2
Sedation 2 2
Perforation of Vessels 2 2
Vomiting 1 1
Ulcer 1 1
Discomfort 1 1
Joint Dislocation 1 1
Osteolysis 1 1
Vertigo 1 1
Perforation 1 1
Pneumonia 1 1
Rash 1 1
Respiratory Distress 1 1
Seroma 1 1
Neuropathy 1 1
Muscle Weakness 1 1
Nausea 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Death 1 1
Exsanguination 1 1
Granuloma 1 1
Wound Dehiscence 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Atrial Fibrillation 1 1
Shaking/Tremors 1 1
Spinal Cord Injury 1 1
Weight Changes 1 1
Cognitive Changes 1 1
Patient Problem/Medical Problem 1 1
Partial thickness (Second Degree) Burn 1 1
Unspecified Heart Problem 1 1
Blister 1 1
Unspecified Tissue Injury 1 1
Unintended Radiation Exposure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AAP Implantate Ag II Apr-06-2020
2 Applied Medical Technology Inc II May-05-2016
3 Biomet, Inc. II Mar-10-2016
4 CooperSurgical, Inc. II Sep-27-2018
5 MEDLINE INDUSTRIES, LP - Northfield II Mar-29-2024
6 Medagent Inc II Feb-23-2024
7 Medtronic Navigation, Inc. II Jan-12-2023
8 Smith & Nephew, Inc. II Aug-17-2020
9 Synthes (USA) Products LLC II May-09-2018
10 TELEFLEX LLC II Jul-05-2023
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