TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
0	1	0	0	0	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
No Device Output	117	117
Migration	94	94
Adverse Event Without Identified Device or Use Problem	71	72
Output Problem	67	67
Device Appears to Trigger Rejection	67	67
Insufficient Device Problem Information	54	54
Improper or Incorrect Procedure or Method	8	8
Lack of Effect	7	7
Noise, Audible	6	6
Positioning Problem	4	4
Malposition of Device	2	2
Fracture	2	2
Incomplete or Inadequate Connection	1	1
Microbial Contamination of Device	1	1
Battery Problem	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	221	221
No Clinical Signs, Symptoms or Conditions	125	125
Skin Tears	39	39
Insufficient Information	31	32
Tissue Breakdown	30	30
Unspecified Infection	13	13
Bacterial Infection	9	9
Implant Pain	8	8
Head Injury	7	7
Total Hearing Loss	5	5
Wound Dehiscence	3	3
Pain	3	3
Pressure Sore/Ulcer	3	3
Skin Infection	2	2
Necrosis	2	2
Middle Ear Inflammation	2	2
Medical device site infection	2	2
Discomfort	2	2
Infectious Otitis Media	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Impaired Healing	1	1
Dizziness	1	1
Bone Fracture(s)	1	1
Inflammation	1	1
Mastoiditis	1	1
Post Operative Wound Infection	1	1
Extraskeletal ossification	1	1
Burning Sensation	1	1
Perforation of Vessels	1	2
Erosion	1	1
Tinnitus	1	1
Meningitis	1	1
Fibrosis	1	1
Facial Paralysis	1	1