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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 210 242

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 763 840
Break 536 536
Material Fragmentation 204 204
Mechanical Jam 148 148
Complete Loss of Power 107 107
Tear, Rip or Hole in Device Packaging 52 52
Delivered as Unsterile Product 47 55
Dull, Blunt 32 32
Failure to Cut 27 27
Excessive Heating 23 23
Detachment of Device or Device Component 22 22
Device Contaminated During Manufacture or Shipping 21 21
Packaging Problem 20 20
Contamination /Decontamination Problem 18 18
Overheating of Device 16 16
Appropriate Term/Code Not Available 16 16
Entrapment of Device 14 14
Defective Device 13 13
Material Separation 11 11
Material Integrity Problem 11 11
Separation Problem 11 11
Adverse Event Without Identified Device or Use Problem 10 10
Contamination 8 8
Insufficient Cooling 7 7
Material Disintegration 7 8
Smoking 7 7
No Apparent Adverse Event 7 7
Material Twisted/Bent 7 7
Insufficient Information 6 6
Material Deformation 6 6
Device Contamination with Chemical or Other Material 5 5
Device-Device Incompatibility 5 5
Fitting Problem 5 5
Continuous Firing 5 5
Mechanical Problem 5 5
Output Problem 5 5
Physical Resistance/Sticking 5 5
Temperature Problem 4 4
Activation Failure 4 4
Melted 4 4
Device Slipped 4 4
Use of Device Problem 4 4
Vibration 4 4
Expiration Date Error 4 4
Manufacturing, Packaging or Shipping Problem 3 3
Flaked 3 3
Component Missing 3 3
Peeled/Delaminated 3 3
Failure to Power Up 3 3
Material Discolored 3 3
Patient Device Interaction Problem 3 3
Power Problem 3 3
Premature Separation 3 3
Material Split, Cut or Torn 2 2
Missing Information 2 2
Component Misassembled 2 2
Noise, Audible 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
Failure to Advance 2 2
Particulates 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Connection Problem 2 2
Device Markings/Labelling Problem 2 2
Device Damaged by Another Device 2 2
Device Unsafe to Use in Environment 1 1
Difficult to Open or Remove Packaging Material 1 1
Device Dislodged or Dislocated 1 1
Failure to Auto Stop 1 1
Failure to Shut Off 1 1
Contamination of Device Ingredient or Reagent 1 1
Human-Device Interface Problem 1 1
Patient-Device Incompatibility 1 1
Defective Component 1 1
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
Material Too Soft/Flexible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Scratched Material 1 1
Material Protrusion/Extrusion 1 1
Naturally Worn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1369 1455
No Consequences Or Impact To Patient 247 247
Insufficient Information 177 179
No Known Impact Or Consequence To Patient 144 144
No Patient Involvement 96 96
Foreign Body In Patient 77 77
Device Embedded In Tissue or Plaque 20 28
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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