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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bur, dental
Product CodeEJL
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 7 7

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
Material Fragmentation 3 3
Bent 3 3
Vibration 3 3
Inadequacy of Device Shape and/or Size 2 2
Entrapment of Device 2 2
Packaging Problem 2 2
Device Dislodged or Dislocated 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
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 22 22
Insufficient Information 18 18
No Known Impact Or Consequence To Patient 16 16
Foreign Body In Patient 14 14
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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