TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	1098	1098
Adverse Event Without Identified Device or Use Problem	448	448
Patient Device Interaction Problem	344	344
Loss of Osseointegration	292	292
Insufficient Information	72	72
Expulsion	33	33
Biocompatibility	20	20
Patient-Device Incompatibility	18	18
Failure to Osseointegrate	17	17
Inadequacy of Device Shape and/or Size	16	16
No Apparent Adverse Event	8	8
Device Appears to Trigger Rejection	7	7
Signal Artifact/Noise	6	6
Output Problem	5	5
Therapeutic or Diagnostic Output Failure	4	4
Loosening of Implant Not Related to Bone-Ingrowth	4	4
Device Dislodged or Dislocated	4	4
Thermal Decomposition of Device	2	2
Failure to Deliver Shock/Stimulation	2	2
Unexpected Therapeutic Results	2	2
Use of Device Problem	2	2
Migration	2	2
Misassembly During Maintenance/Repair	2	2
Material Integrity Problem	2	2
Material Protrusion/Extrusion	1	1
Osseointegration Problem	1	1
Defective Component	1	1
Overheating of Device	1	1
Detachment of Device or Device Component	1	1
Battery Problem	1	1
Malposition of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	377	377
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	313	313
No Clinical Signs, Symptoms or Conditions	233	233
No Code Available	203	203
Pain	190	190
Skin Infection	154	154
Inadequate Osseointegration	136	136
Patient Problem/Medical Problem	125	125
Impaired Healing	112	112
Host-Tissue Reaction	101	101
Skin Inflammation/ Irritation	72	72
Insufficient Information	71	71
Tissue Breakdown	58	58
Discomfort	52	52
Bacterial Infection	49	49
Implant Pain	46	46
Cellulitis	31	31
Hearing Impairment	30	30
No Information	28	28
Scar Tissue	24	24
Head Injury	23	23
Headache	23	23
Skin Irritation	22	22
Purulent Discharge	19	19
Fluid Discharge	18	18
Swelling/ Edema	15	15
Post Operative Wound Infection	14	14
Swelling	14	14
Necrosis	13	13
Inflammation	12	12
Wound Dehiscence	12	12
Skin Disorders	11	11
Erythema	11	11
Necrosis Of Flap Tissue	8	8
Hemorrhage/Bleeding	6	6
Skin Inflammation	6	6
Failure of Implant	5	5
Foreign Body Reaction	5	5
Hematoma	4	4
Burning Sensation	4	4
No Consequences Or Impact To Patient	4	4
No Known Impact Or Consequence To Patient	4	4
Missing Value Reason	3	3
Dizziness	3	3
Therapeutic Response, Decreased	2	2
Ulcer	2	2
Pressure Sores	2	2
Seroma	2	2
Skin Erosion	2	2
Granuloma	2	2
Fall	2	2
Fistula	2	2
Abscess	2	2
Osteomyelitis	2	2
Increased Sensitivity	2	2
Skin Burning Sensation	2	2
Electric Shock	2	2
No Patient Involvement	2	2
Injury	2	2
Scar Excision	2	2
Solid Tumour	2	2
Meningitis	1	1
Autoimmune Disorder	1	1
Ossification	1	1
Irritation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cochlear Americas Inc.	II	Jan-24-2020