TPLC - Total Product Life Cycle

• Device: hearing aid, bone conduction, implanted
• Product Code: MAH
• Regulation Number: 874.3302
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
COCHLEAR AMERICAS
	SUBSTANTIALLY EQUIVALENT	3
OTICON MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	6

MDR Year	MDR Reports	MDR Events
2014	46	46
2015	52	52
2016	308	308
2017	614	614
2018	629	629
2019	635	635
2020	692	692
2021	709	709
2022	712	712
2023	745	745
2024	143	143

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	2337	2337
Patient Device Interaction Problem	957	957
Loss of Osseointegration	755	755
Failure to Osseointegrate	540	540
Adverse Event Without Identified Device or Use Problem	540	540
Insufficient Information	105	105
Loosening of Implant Not Related to Bone-Ingrowth	51	51
Osseointegration Problem	25	25
Inadequacy of Device Shape and/or Size	17	17
Extrusion	16	16
No Apparent Adverse Event	14	14
Detachment of Device or Device Component	12	12
Patient-Device Incompatibility	12	12
Biocompatibility	8	8
Device Appears to Trigger Rejection	5	5
Device Displays Incorrect Message	3	3
Device Operates Differently Than Expected	3	3
Device Dislodged or Dislocated	2	2
Expulsion	2	2
Connection Problem	2	2
Failure to Deliver Shock/Stimulation	2	2
Explanted	2	2
Fracture	2	2
Signal Artifact/Noise	2	2
Thermal Decomposition of Device	2	2
Mechanical Problem	2	2
Product Quality Problem	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	1	1
Migration	1	1
Contamination	1	1
High impedance	1	1
Device remains implanted	1	1
Shelf Life Exceeded	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Improper or Incorrect Procedure or Method	1	1
Microbial Contamination of Device	1	1
Component Missing	1	1
Malposition of Device	1	1
Implant breakage or physical damage	1	1
Expiration Date Error	1	1
Separation Failure	1	1
Defective Device	1	1
Device Operational Issue	1	1
Human-Device Interface Problem	1	1
Compatibility Problem	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	999	999
Inadequate Osseointegration	775	775
Skin Infection	556	556
No Code Available	531	531
Impaired Healing	484	484
Bacterial Infection	409	409
Host-Tissue Reaction	401	401
Pain	320	320
Patient Problem/Medical Problem	309	309
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	235	235
Head Injury	146	146
Skin Inflammation/ Irritation	130	130
No Clinical Signs, Symptoms or Conditions	114	114
Inflammation	86	86
Cellulitis	85	85
Fluid Discharge	80	80
Insufficient Information	68	68
Swelling/ Edema	58	58
Skin Irritation	58	58
Scar Tissue	58	58
Swelling	55	55
Purulent Discharge	52	52
Post Operative Wound Infection	50	50
Hearing Impairment	48	48
No Information	44	44
Discomfort	25	25
Erythema	22	22
Foreign Body Reaction	22	22
Discharge	21	21
Skin Inflammation	21	21
Implant Pain	21	21
Staphylococcus Aureus	19	19
Wound Dehiscence	18	18
Tissue Breakdown	18	18
Abscess	16	16
Irritation	14	14
Skin Disorders	13	13
Hemorrhage/Bleeding	12	12
Failure of Implant	11	11
Headache	11	11
Drug Resistant Bacterial Infection	11	11
Injury	10	10
No Consequences Or Impact To Patient	10	10
Fall	7	7
Granuloma	6	6
Meningitis	6	6
Necrosis Of Flap Tissue	5	5
Necrosis	4	4
Hematoma	4	4
Deafness	4	4
Skin Burning Sensation	4	4
No Known Impact Or Consequence To Patient	3	3
Skin Erosion	3	3
Erosion	3	3
Hypersensitivity/Allergic reaction	3	3
Nausea	2	2
Edema	2	2
Burning Sensation	2	2
Ulcer	2	2
Post Traumatic Wound Infection	2	2
No Patient Involvement	2	2
Missing Value Reason	2	2
Reaction to Medicinal Component of Device	2	2
Osteomyelitis	1	1
Inadequate Pain Relief	1	1
Dizziness	1	1
Scarring	1	1
Atrial Fibrillation	1	1
Undesired Nerve Stimulation	1	1
Rash	1	1
Intracranial Hemorrhage	1	1
Itching Sensation	1	1
Infiltration into Tissue	1	1