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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
2017 284 319
2018 253 371
2019 331 331
2020 276 276
2021 394 394
2022 358 358

Device Problems MDRs with this Device Problem Events in those MDRs
Break 683 836
Fracture 579 579
Material Fragmentation 102 102
Mechanical Jam 93 93
Complete Loss of Power 66 66
Device Operates Differently Than Expected 56 56
Tear, Rip or Hole in Device Packaging 47 47
Packaging Problem 30 181
Dull, Blunt 25 25
Detachment of Device or Device Component 24 24
Detachment Of Device Component 23 23
Delivered as Unsterile Product 21 21
Overheating of Device 21 21
Device Inoperable 19 19
Contamination /Decontamination Problem 18 18
Device Contaminated During Manufacture or Shipping 16 16
Material Deformation 16 16
Mechanical Problem 15 15
Failure to Cut 14 14
Device Contamination with Chemical or Other Material 14 14
Adverse Event Without Identified Device or Use Problem 13 13
Vibration 13 13
Material Separation 13 13
Entrapment of Device 12 12
Excessive Heating 12 12
Separation Problem 11 11
Bent 11 11
Difficult to Remove 8 8
Appropriate Term/Code Not Available 8 8
Metal Shedding Debris 7 7
Contamination 7 7
Insufficient Cooling 6 6
Output below Specifications 6 6
Material Twisted/Bent 6 6
Smoking 5 5
Material Integrity Problem 5 5
Device Packaging Compromised 5 5
Insufficient Information 5 5
No Apparent Adverse Event 4 4
Noise, Audible 4 4
Output Problem 4 4
Crack 4 4
Material Disintegration 4 4
Thermal Decomposition of Device 4 4
Flaked 4 4
Fitting Problem 4 4
Defective Component 4 4
Component Missing 4 4
Difficult To Position 4 4
Failure to Power Up 4 4
Particulates 3 3
Peeled/Delaminated 3 3
Loose or Intermittent Connection 3 3
Device Slipped 3 3
Fluid/Blood Leak 3 3
Melted 3 3
Material Discolored 3 3
Corroded 3 3
Temperature Problem 3 3
Device-Device Incompatibility 3 3
Device Operational Issue 3 3
Premature Separation 3 3
Power Problem 2 2
Scratched Material 2 2
Naturally Worn 2 2
Degraded 2 2
Disconnection 2 2
Intermittent Continuity 2 2
Continuous Firing 2 2
Leak/Splash 2 2
Material Frayed 2 2
Self-Activation or Keying 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Emits Odor 2 2
Connection Problem 2 2
Defective Device 2 2
Device Or Device Fragments Location Unknown 1 1
Patient-Device Incompatibility 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Damaged Prior to Use 1 1
Expiration Date Error 1 1
Failure to Disconnect 1 1
Unsealed Device Packaging 1 1
Use of Device Problem 1 1
Difficult to Insert 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Fire 1 1
Device Abrasion From Instrument Or Another Object 1 1
Migration or Expulsion of Device 1 1
Misconnection 1 1
Moisture Damage 1 1
Component Falling 1 1
Burst Container or Vessel 1 1
Air Leak 1 1
Failure To Adhere Or Bond 1 1
Electrical /Electronic Property Problem 1 1
Failure to Deliver Energy 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 773 773
No Consequences Or Impact To Patient 426 579
No Known Impact Or Consequence To Patient 347 420
No Patient Involvement 185 302
Insufficient Information 125 125
Foreign Body In Patient 64 64
Device Embedded In Tissue or Plaque 29 29
No Information 18 18
No Code Available 11 11
Burn(s) 11 11
Not Applicable 9 9
Radiation Exposure, Unintended 8 8
Burn, Thermal 7 7
Laceration(s) 5 5
Pain 4 4
Superficial (First Degree) Burn 4 4
Injury 4 4
Patient Problem/Medical Problem 4 4
Abrasion 3 3
Tissue Damage 3 3
Necrosis 2 2
Bone Fracture(s) 2 2
Hemorrhage/Bleeding 2 2
Hypoxia 1 1
Unspecified Infection 1 1
Purulent Discharge 1 1
Edema 1 1
Extravasation 1 1
Perforation of Vessels 1 1
Paralysis 1 1
Skin Discoloration 1 1
Swelling 1 1
Hypovolemia 1 1
Discomfort 1 1
Limited Mobility Of The Implanted Joint 1 1
Tissue Breakdown 1 1
Muscle/Tendon Damage 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Stryker Instruments Div. of Stryker Corporation II Apr-24-2019
2 Synvasive Technology Inc II Apr-06-2020
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