TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	1395	1395
Patient Device Interaction Problem	1123	1123
Adverse Event Without Identified Device or Use Problem	539	539
Loss of Osseointegration	516	516
Failure to Osseointegrate	209	209
Insufficient Information	84	84
Loosening of Implant Not Related to Bone-Ingrowth	60	60
Osseointegration Problem	40	40
Inadequacy of Device Shape and/or Size	17	17
No Apparent Adverse Event	14	14
Detachment of Device or Device Component	12	12
Biocompatibility	8	8
Patient-Device Incompatibility	7	7
Device Appears to Trigger Rejection	5	5
Signal Artifact/Noise	2	2
Mechanical Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Thermal Decomposition of Device	2	2
Product Quality Problem	2	2
Device Dislodged or Dislocated	2	2
Fracture	2	2
Connection Problem	2	2
Failure to Deliver Shock/Stimulation	2	2
Compatibility Problem	1	1
Expulsion	1	1
Output Problem	1	1
High impedance	1	1
Defective Device	1	1
Microbial Contamination of Device	1	1
Contamination	1	1
Use of Device Problem	1	1
Migration	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	800	800
Skin Infection	682	682
Impaired Healing	530	530
Inadequate Osseointegration	503	503
No Code Available	297	297
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	248	248
Pain	200	200
Host-Tissue Reaction	162	162
Skin Inflammation/ Irritation	139	139
Patient Problem/Medical Problem	133	133
No Clinical Signs, Symptoms or Conditions	122	122
Head Injury	109	109
Bacterial Infection	104	104
Insufficient Information	72	72
Cellulitis	69	69
Swelling/ Edema	60	60
Fluid Discharge	59	59
Scar Tissue	57	57
Inflammation	51	51
Post Operative Wound Infection	50	50
Purulent Discharge	48	48
Hearing Impairment	29	29
Implant Pain	26	26
Erythema	26	26
Swelling	26	26
Skin Irritation	25	25
Tissue Breakdown	21	21
Wound Dehiscence	19	19
No Information	17	17
Discharge	15	15
Hemorrhage/Bleeding	14	14
Skin Inflammation	14	14
Skin Disorders	14	14
Discomfort	12	12
Abscess	12	12
Drug Resistant Bacterial Infection	11	11
Failure of Implant	9	9
Headache	9	9
Fall	7	7
Necrosis	7	7
Granuloma	6	6
Staphylococcus Aureus	4	4
Foreign Body Reaction	4	4
Meningitis	4	4
Skin Burning Sensation	4	4
Necrosis Of Flap Tissue	3	3
No Patient Involvement	2	2
Post Traumatic Wound Infection	2	2
Reaction to Medicinal Component of Device	2	2
Missing Value Reason	2	2