TPLC - Total Product Life Cycle

• Device: instruments, dental hand
• Regulation Description: Dental hand instrument.
• Product Code: DZN
• Regulation Number: 872.4565
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	12	12
2020	15	15
2021	21	21
2022	26	26
2023	38	38
2024	69	69
2025	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	161	161
Separation Failure	10	10
Material Integrity Problem	7	7
Material Deformation	6	6
Peeled/Delaminated	5	5
Flaked	5	5
Fracture	2	2
Component Incompatible	2	2
Patient-Device Incompatibility	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Patient Device Interaction Problem	1	1
Unraveled Material	1	1
Problem with Sterilization	1	1
Failure to Osseointegrate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Separation	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	142	142
Insufficient Information	34	34
No Consequences Or Impact To Patient	12	12
No Known Impact Or Consequence To Patient	9	9
Failure of Implant	2	2
No Patient Involvement	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Intraoperative Pain	1	1
No Information	1	1
Tooth Fracture	1	1
Foreign Body In Patient	1	1
Erythema	1	1
Device Embedded In Tissue or Plaque	1	1