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TPLC
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show TPLC since
2009
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2014
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2019
2020
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2024
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Device
drill, dental, intraoral
Product Code
DZA
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
Detachment Of Device Component
4
4
Overheating of Device
4
4
Difficult to Remove
3
3
Mechanical Problem
3
3
Material Fragmentation
2
2
Component Falling
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
Material Integrity Problem
1
1
Naturally Worn
1
1
Positioning Problem
1
1
Temperature Problem
1
1
Insufficient Information
1
1
Excessive Heating
1
1
Separation Problem
1
1
Failure to Power Up
1
1
Failure To Service
1
1
Sticking
1
1
Vibration
1
1
Defective Device
1
1
Contamination /Decontamination Problem
1
1
Material Disintegration
1
1
Entrapment of Device
1
1
Nonstandard Device
1
1
No Device Output
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
Device Embedded In Tissue or Plaque
12
12
No Clinical Signs, Symptoms or Conditions
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
Injury
1
1
No Patient Involvement
1
1
Laceration(s)
1
1
Skin Discoloration
1
1
Failure of Implant
1
1
Blister
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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