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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device bur, surgical, general & plastic surgery
Product CodeGFF
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2018 83 83
2019 80 80
2020 23 23
2021 76 76
2022 67 67

Device Problems MDRs with this Device Problem Events in those MDRs
Break 132 132
Material Fragmentation 53 53
Fracture 31 31
Overheating of Device 26 26
Failure to Cut 22 22
Material Twisted/Bent 18 18
Detachment of Device or Device Component 15 15
Entrapment of Device 10 10
Metal Shedding Debris 5 5
Vibration 5 5
Material Integrity Problem 4 4
Flaked 4 4
Loose or Intermittent Connection 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Melted 3 3
Fluid/Blood Leak 3 3
Device-Device Incompatibility 3 3
Bent 3 3
Difficult to Remove 2 2
Material Separation 2 2
Excessive Heating 2 2
Detachment Of Device Component 2 2
Unintended Collision 2 2
Peeled/Delaminated 2 2
Mechanical Problem 2 2
Output Problem 2 2
Temperature Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Noise, Audible 1 1
Activation Problem 1 1
Packaging Problem 1 1
Defective Device 1 1
Activation, Positioning or Separation Problem 1 1
Loss of or Failure to Bond 1 1
Split 1 1
Degraded 1 1
Unintended Ejection 1 1
Device Difficult to Setup or Prepare 1 1
Device Slipped 1 1
Smoking 1 1
Scratched Material 1 1
Explosion 1 1
Thermal Decomposition of Device 1 1
Connection Problem 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Unintended Movement 1 1
Electro-Static Discharge 1 1
Sparking 1 1
Device Operates Differently Than Expected 1 1
Material Disintegration 1 1
Fire 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 108 108
No Consequences Or Impact To Patient 92 92
No Known Impact Or Consequence To Patient 30 30
Foreign Body In Patient 29 29
Insufficient Information 26 26
Device Embedded In Tissue or Plaque 24 24
Burn, Thermal 10 10
No Patient Involvement 6 6
No Information 3 3
No Code Available 2 2
Failure of Implant 2 2
Superficial (First Degree) Burn 1 1
Shock 1 1
Burn(s) 1 1
Sinus Perforation 1 1
Physical Entrapment 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Apr-23-2019
2 Brasseler USA I Lp II Dec-02-2019
3 In2Bones, SAS II Mar-19-2021
4 Wright Medical Technology, Inc. II Nov-25-2019
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