TPLC - Total Product Life Cycle

• Device: needle, dental
• Product Code: DZM
• Regulation Number: 872.4730
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	31	31
2020	16	16
2021	41	65
2022	35	35
2023	34	34
2024	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	72
Material Fragmentation	37	40
Detachment of Device or Device Component	29	29
Material Separation	17	19
Fitting Problem	9	9
Material Puncture/Hole	8	8
Loose or Intermittent Connection	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Fluid/Blood Leak	3	7
Product Quality Problem	3	3
Device Contamination with Body Fluid	3	7
Device Contamination with Chemical or Other Material	3	3
Material Integrity Problem	2	2
Disconnection	2	2
Material Twisted/Bent	2	2
Unintended Movement	1	1
Device Handling Problem	1	2
Fail-Safe Did Not Operate	1	1
Entrapment of Device	1	1
Off-Label Use	1	3
Use of Device Problem	1	1
Material Protrusion/Extrusion	1	1
Device Dislodged or Dislocated	1	1
Fail-Safe Problem	1	1
Connection Problem	1	1
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	54	62
Foreign Body In Patient	48	62
Needle Stick/Puncture	44	49
Exposure to Body Fluids	35	35
No Consequences Or Impact To Patient	11	11
No Clinical Signs, Symptoms or Conditions	9	9
Pain	5	5
No Information	4	4
No Known Impact Or Consequence To Patient	3	3
Necrosis	3	3
Hemorrhage/Bleeding	2	2
No Code Available	2	2
Discomfort	2	2
Unspecified Tissue Injury	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Peripheral Nervous Injury	1	1
Pyogenic Infection	1	1
No Patient Involvement	1	1
Inflammation	1	1
Foreign Body Reaction	1	1
Ulcer	1	1