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	24	24

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	60	72
Material Fragmentation	43	46
Detachment of Device or Device Component	29	29
Material Separation	21	23
Fitting Problem	9	9
Material Puncture/Hole	9	9
Loose or Intermittent Connection	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Device Contamination with Chemical or Other Material	3	3
Material Twisted/Bent	3	3
Off-Label Use	3	5
Product Quality Problem	3	3
Fluid/Blood Leak	3	7
Device Contamination with Body Fluid	3	7
Fracture	2	2
Disconnection	2	2
Entrapment of Device	2	2
Fail-Safe Problem	2	2
Material Integrity Problem	2	2
Material Protrusion/Extrusion	1	1
Unintended Movement	1	1
Device Handling Problem	1	2
Fail-Safe Did Not Operate	1	1
Connection Problem	1	1
Device Dislodged or Dislocated	1	1
Defective Component	1	1
Use of Device Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	62	70
Foreign Body In Patient	49	63
Needle Stick/Puncture	45	50
Exposure to Body Fluids	36	36
No Consequences Or Impact To Patient	11	11
No Clinical Signs, Symptoms or Conditions	9	9
Pain	7	7
Discomfort	6	6
Necrosis	5	5
No Information	4	4
No Known Impact Or Consequence To Patient	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Tachycardia	2	2
Unspecified Tissue Injury	2	2
Swelling/ Edema	2	2
Hemorrhage/Bleeding	2	2
Bruise/Contusion	2	2
Inflammation	1	1
Foreign Body Reaction	1	1
No Patient Involvement	1	1
Peripheral Nervous Injury	1	1
Pyogenic Infection	1	1
Ulcer	1	1