TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2017	25	25
2018	38	38
2019	31	31
2020	16	16
2021	41	65
2022	35	35
2023	34	34
2024	6	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	105	117
Material Fragmentation	36	39
Detachment of Device or Device Component	36	36
Material Separation	15	17
Fitting Problem	9	9
Material Puncture/Hole	8	8
Loose or Intermittent Connection	6	6
Product Quality Problem	5	5
Disconnection	5	5
Entrapment of Device	5	5
Leak/Splash	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Contamination with Body Fluid	3	7
Device Contamination with Chemical or Other Material	3	3
Fluid/Blood Leak	3	7
Detachment Of Device Component	3	3
Bent	3	3
Difficult to Remove	2	2
Material Integrity Problem	2	2
Material Twisted/Bent	2	2
Connection Problem	2	2
Device Dislodged or Dislocated	1	1
Fail-Safe Problem	1	1
Unintended Movement	1	1
Device Handling Problem	1	2
Fail-Safe Did Not Operate	1	1
Material Protrusion/Extrusion	1	1
Off-Label Use	1	3
Defective Component	1	1
Sticking	1	1
Use of Device Problem	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	92	100
Foreign Body In Patient	59	73
Needle Stick/Puncture	40	45
Exposure to Body Fluids	31	31
No Consequences Or Impact To Patient	16	16
No Known Impact Or Consequence To Patient	9	9
No Clinical Signs, Symptoms or Conditions	9	9
Pain	7	7
No Code Available	5	5
No Information	4	4
Necrosis	3	3
Hemorrhage/Bleeding	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
Inflammation	1	1
Foreign Body Reaction	1	1
Ulcer	1	1
Discomfort	1	1
Injury	1	1
No Patient Involvement	1	1