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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
2020 23 23
2021 76 76
2022 68 68
2023 96 101
2024 124 134

Device Problems MDRs with this Device Problem Events in those MDRs
Break 133 133
Material Fragmentation 79 79
Fracture 46 61
Failure to Cut 26 26
Detachment of Device or Device Component 15 15
Material Twisted/Bent 14 14
Defective Device 13 13
Device Contaminated During Manufacture or Shipping 8 8
Entrapment of Device 8 8
Melted 6 6
Excessive Heating 6 6
Device-Device Incompatibility 4 4
Material Integrity Problem 4 4
Material Separation 4 4
Mechanical Jam 3 3
Physical Resistance/Sticking 3 3
Overheating of Device 3 3
Device Emits Odor 3 3
Temperature Problem 2 2
Loose or Intermittent Connection 2 2
Flaked 2 2
Output Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Retraction Problem 2 2
Connection Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Explosion 1 1
Activation Failure 1 1
Failure to Fire 1 1
Packaging Problem 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Mechanics Altered 1 1
Thermal Decomposition of Device 1 1
Use of Device Problem 1 1
Device Difficult to Setup or Prepare 1 1
Unintended Ejection 1 1
Degraded 1 1
Scratched Material 1 1
Defective Component 1 1
Vibration 1 1
Smoking 1 1
Failure to Sense 1 1
Unintended Movement 1 1
Separation Failure 1 1
Material Disintegration 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 282 297
Insufficient Information 67 78
Foreign Body In Patient 36 36
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
Sinus Perforation 1 1

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