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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
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeGFF
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2020 23 23
2021 76 76
2022 68 68
2023 96 101
2024 124 134
2025 63 65

Device Problems MDRs with this Device Problem Events in those MDRs
Break 159 159
Material Fragmentation 99 99
Fracture 54 71
Failure to Cut 26 26
Detachment of Device or Device Component 15 15
Material Twisted/Bent 15 15
Defective Device 13 13
Device Contaminated During Manufacture or Shipping 10 10
Defective Component 9 9
Entrapment of Device 8 8
Melted 6 6
Excessive Heating 6 6
Physical Resistance/Sticking 5 5
Device-Device Incompatibility 4 4
Overheating of Device 4 4
Material Separation 4 4
Material Integrity Problem 4 4
Mechanical Jam 3 3
Device Emits Odor 3 3
Temperature Problem 2 2
Loose or Intermittent Connection 2 2
Flaked 2 2
Device Dislodged or Dislocated 2 2
Retraction Problem 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Unintended Movement 2 2
Output Problem 2 2
Use of Device Problem 1 1
Device Difficult to Setup or Prepare 1 1
Thermal Decomposition of Device 1 1
Unintended Ejection 1 1
Mechanics Altered 1 1
Degraded 1 1
Material Deformation 1 1
Packaging Problem 1 1
Scratched Material 1 1
Vibration 1 1
Failure to Fire 1 1
Smoking 1 1
Activation Failure 1 1
Explosion 1 1
Failure to Sense 1 1
Appropriate Term/Code Not Available 1 1
Separation Failure 1 1
Material Disintegration 1 1
Connection Problem 1 1
Separation Problem 1 1
Activation, Positioning or Separation Problem 1 1
Unstable 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 336 353
Insufficient Information 72 83
Foreign Body In Patient 41 41
Device Embedded In Tissue or Plaque 8 8
No Consequences Or Impact To Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Burn(s) 3 3
No Known Impact Or Consequence To Patient 2 2
Superficial (First Degree) Burn 1 1
Failure of Implant 1 1
Nicks, cuts or tears of dura or other tissues by device 1 1
Sinus Perforation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 In2Bones, SAS II Mar-19-2021
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