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	1131	1131
Adverse Event Without Identified Device or Use Problem	459	459
Patient Device Interaction Problem	380	380
Loss of Osseointegration	304	304
Insufficient Information	75	75
Expulsion	41	41
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	11	11
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Device Appears to Trigger Rejection	7	7
Signal Artifact/Noise	6	6
Output Problem	6	6
Therapeutic or Diagnostic Output Failure	4	4
Device Dislodged or Dislocated	4	4
Material Integrity Problem	2	2
Use of Device Problem	2	2
Thermal Decomposition of Device	2	2
Misassembly During Maintenance/Repair	2	2
Migration	2	2
Unexpected Therapeutic Results	2	2
Failure to Deliver Shock/Stimulation	2	2
Malposition of Device	1	1
Defective Component	1	1
Battery Problem	1	1
Detachment of Device or Device Component	1	1
Material Protrusion/Extrusion	1	1
Overheating of Device	1	1
Osseointegration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	379	379
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	337	337
No Clinical Signs, Symptoms or Conditions	251	251
No Code Available	203	203
Pain	199	199
Skin Infection	174	174
Inadequate Osseointegration	151	151
Patient Problem/Medical Problem	125	125
Impaired Healing	117	117
Host-Tissue Reaction	101	101
Insufficient Information	73	73
Skin Inflammation/ Irritation	72	72
Tissue Breakdown	67	67
Discomfort	54	54
Bacterial Infection	49	49
Implant Pain	46	46
Cellulitis	33	33
Hearing Impairment	31	31
No Information	28	28
Head Injury	28	28
Scar Tissue	25	25
Headache	23	23
Skin Irritation	22	22
Purulent Discharge	21	21
Necrosis	18	18
Fluid Discharge	18	18
Wound Dehiscence	16	16
Swelling/ Edema	15	15
Post Operative Wound Infection	14	14
Swelling	14	14
Inflammation	12	12
Erythema	12	12
Skin Disorders	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
No Consequences Or Impact To Patient	4	4
Burning Sensation	4	4
No Known Impact Or Consequence To Patient	4	4
Hematoma	4	4
Missing Value Reason	3	3
Dizziness	3	3
Pressure Sores	3	3
Osteomyelitis	2	2
No Patient Involvement	2	2
Injury	2	2
Fall	2	2
Skin Erosion	2	2

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