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TPLC
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show TPLC since
2009
2010
2011
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2014
2015
2016
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2019
2020
2021
2022
2023
2024
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Device
bur, dental
Product Code
EJL
Regulation Number
872.3240
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
7
7
2016
18
18
2017
19
19
2018
15
15
2019
17
17
2020
7
7
2021
21
21
2022
19
19
2023
9
9
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
77
77
Fracture
10
10
Material Separation
10
10
Detachment of Device or Device Component
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Detachment Of Device Component
5
5
Insufficient Information
4
4
Bent
3
3
Vibration
3
3
Inadequacy of Device Shape and/or Size
2
2
Entrapment of Device
2
2
Material Fragmentation
2
2
Packaging Problem
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Use of Device Problem
2
2
Appropriate Term/Code Not Available
1
1
Sharp Edges
1
1
Device Fell
1
1
Positioning Failure
1
1
Failure to Charge
1
1
Device Slipped
1
1
Device Markings/Labelling Problem
1
1
Device Dislodged or Dislocated
1
1
Improper or Incorrect Procedure or Method
1
1
No Audible Prompt/Feedback
1
1
Tear, Rip or Hole in Device Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
34
34
No Clinical Signs, Symptoms or Conditions
21
21
Insufficient Information
18
18
No Known Impact Or Consequence To Patient
16
16
Foreign Body In Patient
12
12
Device Embedded In Tissue or Plaque
12
12
No Code Available
7
7
Laceration(s)
7
7
Injury
6
6
No Patient Involvement
6
6
Abrasion
3
3
No Information
3
3
Perforation
2
2
Failure of Implant
2
2
Needle Stick/Puncture
2
2
Tissue Damage
1
1
Tissue Breakdown
1
1
Radiation Exposure, Unintended
1
1
Burn(s)
1
1
Hemorrhage/Bleeding
1
1
Pain
1
1
Sedation
1
1
Tooth Fracture
1
1
Unspecified Tissue Injury
1
1
Swelling/ Edema
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet Microfixation, Inc.
II
Sep-08-2009
2
Brasseler USA I Lp
II
Feb-07-2024
3
Coltene /Whaledent AG
II
Sep-04-2019
4
Coltene Whaledent Inc
II
Nov-17-2020
5
Coltene Whaledent Inc
II
May-14-2018
6
Hager & Meisinger Gmbh
II
Sep-04-2020
7
Hager & Meisinger Gmbh
II
Nov-19-2019
8
Jjgc Industria E Comercio De Materials Dentarios Sa
II
Jan-30-2020
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