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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drill, dental, intraoral
Product CodeDZA
Regulation Number 872.4130
Device Class 1

MDR Year MDR Reports MDR Events
2014 17 17
2015 9 9
2016 14 14
2017 13 13
2018 14 14
2019 14 14
2020 9 9
2021 8 8
2022 1 1
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 55 55
Material Separation 24 24
Fracture 12 12
Overheating of Device 4 4
Detachment Of Device Component 4 4
Mechanical Problem 3 3
Difficult to Remove 3 3
Material Fragmentation 2 2
Material Too Rigid or Stiff 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Detachment of Device or Device Component 2 2
Component Falling 2 2
Separation Problem 1 1
Entrapment of Device 1 1
Insufficient Information 1 1
Material Disintegration 1 1
Positioning Problem 1 1
Material Integrity Problem 1 1
Defective Device 1 1
Vibration 1 1
Contamination /Decontamination Problem 1 1
Failure to Power Up 1 1
Sticking 1 1
Excessive Heating 1 1
Nonstandard Device 1 1
Naturally Worn 1 1
Failure To Service 1 1
No Device Output 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 41 41
No Known Impact Or Consequence To Patient 18 18
No Information 14 14
No Clinical Signs, Symptoms or Conditions 12 12
Device Embedded In Tissue or Plaque 12 12
Foreign Body In Patient 5 5
Burn(s) 4 4
Insufficient Information 4 4
No Code Available 3 3
Partial thickness (Second Degree) Burn 3 3
Unspecified Infection 2 2
Swelling 2 2
Failure of Implant 1 1
Blister 1 1
Skin Discoloration 1 1
Injury 1 1
No Patient Involvement 1 1
Laceration(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet 3i, LLC II Sep-01-2009
2 Zimmer Dental Inc II Sep-22-2017
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