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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
2018 254 372
2019 331 331
2020 276 276
2021 394 394
2022 442 442
2023 263 300

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 704 734
Break 623 741
Material Fragmentation 134 134
Mechanical Jam 123 123
Complete Loss of Power 84 84
Tear, Rip or Hole in Device Packaging 52 52
Delivered as Unsterile Product 32 39
Dull, Blunt 31 31
Packaging Problem 31 149
Detachment of Device or Device Component 25 25
Contamination /Decontamination Problem 24 24
Failure to Cut 23 23
Overheating of Device 20 20
Excessive Heating 19 19
Device Contaminated During Manufacture or Shipping 17 17
Appropriate Term/Code Not Available 17 17
Entrapment of Device 14 14
Material Separation 11 11
Adverse Event Without Identified Device or Use Problem 11 11
Material Integrity Problem 11 11
Separation Problem 11 11
Device Operates Differently Than Expected 10 10
Vibration 9 9
Detachment Of Device Component 9 9
Contamination 8 8
Smoking 8 8
Material Deformation 8 8
Device Contamination with Chemical or Other Material 8 8
Insufficient Cooling 7 7
Material Disintegration 7 7
Mechanical Problem 7 7
Material Twisted/Bent 6 6
No Apparent Adverse Event 6 6
Insufficient Information 5 5
Output below Specifications 5 5
Output Problem 5 5
Noise, Audible 5 5
Temperature Problem 4 4
Device-Device Incompatibility 4 4
Melted 4 4
Flaked 4 4
Continuous Firing 4 4
Failure to Power Up 4 4
Defective Device 4 4
Fitting Problem 4 4
Component Missing 3 3
Expiration Date Error 3 3
Connection Problem 3 3
Difficult to Remove 3 3
Particulates 3 3
Peeled/Delaminated 3 3
Device Inoperable 3 3
Use of Device Problem 3 3
Metal Shedding Debris 3 3
Device Slipped 3 3
Thermal Decomposition of Device 3 3
Bent 3 3
Material Discolored 3 3
Fluid/Blood Leak 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Power Problem 3 3
Premature Separation 3 3
Scratched Material 2 2
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Naturally Worn 2 2
Material Frayed 2 2
Device Emits Odor 2 2
Leak/Splash 2 2
Loose or Intermittent Connection 2 2
Disconnection 2 2
Corroded 2 2
Crack 2 2
Degraded 2 2
Self-Activation or Keying 2 2
Inadequacy of Device Shape and/or Size 2 2
Defective Component 2 2
Device Damaged Prior to Use 1 1
Failure to Disconnect 1 1
Contamination of Device Ingredient or Reagent 1 1
Patient-Device Incompatibility 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Device Packaging Compromised 1 1
Unsealed Device Packaging 1 1
Retraction Problem 1 1
Product Quality Problem 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Air Leak 1 1
Burst Container or Vessel 1 1
Component Falling 1 1
Device Abrasion From Instrument Or Another Object 1 1
Misconnection 1 1
Moisture Damage 1 1
Nonstandard Device 1 1
Difficult to Insert 1 1
Material Erosion 1 1
Fire 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1082 1117
No Consequences Or Impact To Patient 344 462
No Known Impact Or Consequence To Patient 224 264
No Patient Involvement 146 230
Insufficient Information 142 144
Foreign Body In Patient 73 73
Device Embedded In Tissue or Plaque 21 21
No Information 11 11
No Code Available 11 11
Not Applicable 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Burn(s) 8 8
Burn, Thermal 7 7
Superficial (First Degree) Burn 5 5
Laceration(s) 5 5
Pain 5 5
Injury 4 4
Unspecified Infection 3 3
Hemorrhage/Bleeding 3 3
Tissue Damage 3 3
Patient Problem/Medical Problem 3 3
Unspecified Tissue Injury 2 2
Bone Fracture(s) 2 2
Abrasion 1 1
Purulent Discharge 1 1
Edema 1 1
Paralysis 1 1
Skin Discoloration 1 1
Swelling 1 1
Perforation of Vessels 1 1
Hypoxia 1 1
Hypovolemia 1 1
Discomfort 1 1
Muscle/Tendon Damage 1 1
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 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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