TPLC - Total Product Life Cycle

• Device: implant, hearing, active, middle ear, partially implanted
• Product Code: MPV
• Device Class: 3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
1	0	1	0	0	0

MDR Year	MDR Reports	MDR Events
2020	54	54
2021	69	69
2022	56	56
2023	68	68
2024	80	80
2025	22	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	112	112
No Device Output	84	84
Migration	76	76
Device Appears to Trigger Rejection	60	60
Adverse Event Without Identified Device or Use Problem	51	51
Insufficient Information	44	44
Lack of Effect	5	5
Noise, Audible	3	3
Improper or Incorrect Procedure or Method	3	3
Malposition of Device	2	2
Positioning Problem	2	2
No Apparent Adverse Event	1	1
Intermittent Energy Output	1	1
Incomplete or Inadequate Connection	1	1
Circuit Failure	1	1
Fracture	1	1
Microbial Contamination of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	273	273
No Clinical Signs, Symptoms or Conditions	36	36
Skin Tears	30	30
Insufficient Information	26	26
Tissue Breakdown	20	20
Unspecified Infection	8	8
Bacterial Infection	8	8
Implant Pain	6	6
Total Hearing Loss	5	5
Head Injury	5	5
Wound Dehiscence	4	4
Pain	3	3
Tissue Damage	3	3
Pressure Sores	3	3
Impaired Healing	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Skin Infection	2	2
No Information	2	2
Necrosis	2	2
Discomfort	2	2
Hearing Impairment	1	1
Dizziness	1	1
Bone Fracture(s)	1	1
Vertigo	1	1
Perforation of Vessels	1	1
Headache	1	1
Meningitis	1	1
Granuloma	1	1