TPLC - Total Product Life Cycle

• Device: bur, dental
• Regulation Description: Dental bur.
• Product Code: EJL
• Regulation Number: 872.3240
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2020	7	8
2021	21	21
2022	19	19
2023	9	9
2024	25	25
2025	49	50

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	57	58
Detachment of Device or Device Component	15	15
Fracture	14	15
Material Fragmentation	5	5
Adverse Event Without Identified Device or Use Problem	4	4
Material Separation	4	4
Insufficient Information	3	3
Device Dislodged or Dislocated	2	2
Device Slipped	1	1
Entrapment of Device	1	1
Device Markings/Labelling Problem	1	1
Unintended Ejection	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Sharp Edges	1	1
Misconnection	1	1
Packaging Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	54	55
Insufficient Information	30	30
Foreign Body In Patient	25	25
Laceration(s)	9	9
Device Embedded In Tissue or Plaque	6	6
Abrasion	3	3
Needle Stick/Puncture	2	2
No Consequences Or Impact To Patient	2	3
Superficial (First Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Failure of Implant	1	1
No Code Available	1	1
Sinus Perforation	1	1
Tooth Fracture	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Tissue Damage	1	1
Hemorrhage/Bleeding	1	1
Tissue Breakdown	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Brasseler USA I Lp	II	Feb-07-2024
2	Coltene Whaledent Inc	II	Nov-17-2020
3	Hager & Meisinger Gmbh	II	Sep-04-2020
4	Jjgc Industria E Comercio De Materials Dentarios Sa	II	Jan-30-2020
5	Premier Dental Products Co	II	Mar-21-2025