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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device blade, saw, general & plastic surgery, surgical
Product CodeGFA
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 331 331
2020 276 276
2021 394 394
2022 442 442
2023 383 437
2024 114 132

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 739 803
Break 523 523
Material Fragmentation 182 182
Mechanical Jam 142 142
Complete Loss of Power 102 102
Tear, Rip or Hole in Device Packaging 52 52
Delivered as Unsterile Product 43 51
Dull, Blunt 31 31
Failure to Cut 27 27
Device Contaminated During Manufacture or Shipping 21 21
Excessive Heating 21 21
Packaging Problem 20 20
Detachment of Device or Device Component 20 20
Contamination /Decontamination Problem 18 18
Appropriate Term/Code Not Available 16 16
Overheating of Device 15 15
Entrapment of Device 14 14
Material Integrity Problem 11 11
Material Separation 11 11
Separation Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Defective Device 9 9
Contamination 8 8
Insufficient Cooling 7 7
Smoking 7 7
Material Twisted/Bent 7 7
Material Deformation 6 6
No Apparent Adverse Event 6 6
Insufficient Information 6 6
Material Disintegration 6 6
Continuous Firing 5 5
Mechanical Problem 5 5
Fitting Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Device-Device Incompatibility 5 5
Output Problem 5 5
Temperature Problem 4 4
Expiration Date Error 4 4
Vibration 4 4
Melted 4 4
Peeled/Delaminated 3 3
Failure to Power Up 3 3
Material Discolored 3 3
Use of Device Problem 3 3
Flaked 3 3
Device Slipped 3 3
Component Missing 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Patient Device Interaction Problem 3 3
Power Problem 3 3
Premature Separation 3 3
Physical Resistance/Sticking 3 3
Material Split, Cut or Torn 2 2
Component Misassembled 2 2
Noise, Audible 2 2
Device Damaged by Another Device 2 2
Connection Problem 2 2
Particulates 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Disconnection 2 2
Thermal Decomposition of Device 2 2
Corroded 2 2
Crack 2 2
Degraded 2 2
Device Emits Odor 2 2
Material Erosion 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Fire 1 1
Misconnection 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1
Self-Activation or Keying 1 1
Burst Container or Vessel 1 1
Electrical /Electronic Property Problem 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Defective Component 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Markings/Labelling Problem 1 1
Difficult to Open or Remove Packaging Material 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Device Unsafe to Use in Environment 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Material Too Soft/Flexible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Scratched Material 1 1
Naturally Worn 1 1
Device Fell 1 1
Activation Problem 1 1
Misassembled During Installation 1 1
Device Contaminated at the User Facility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1281 1353
No Consequences Or Impact To Patient 247 247
Insufficient Information 167 169
No Known Impact Or Consequence To Patient 144 144
No Patient Involvement 96 96
Foreign Body In Patient 76 76
Device Embedded In Tissue or Plaque 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Burn(s) 8 8
No Code Available 7 7
No Information 6 6
Laceration(s) 6 6
Pain 5 5
Not Applicable 5 5
Superficial (First Degree) Burn 5 5
Unspecified Infection 4 4
Unspecified Tissue Injury 4 4
Burn, Thermal 3 3
Tissue Damage 3 3
Hemorrhage/Bleeding 3 3
Bone Fracture(s) 2 2
Patient Problem/Medical Problem 2 2
Injury 2 2
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 1 1
Muscle/Tendon Damage 1 1
Abrasion 1 1
Purulent Discharge 1 1
Edema 1 1
Hypersensitivity/Allergic reaction 1 1
Hypoxia 1 1
Failure of Implant 1 1
Perforation of Vessels 1 1
Hypovolemia 1 1
Discomfort 1 1
Skin Discoloration 1 1
Swelling 1 1
Myocardial Infarction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 MEDLINE INDUSTRIES, LP - Northfield II Jan-11-2023
2 Stryker Instruments Div. of Stryker Corporation II Apr-24-2019
3 Synvasive Technology Inc II Apr-06-2020
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