TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
AUDIFON-USA INC.
	SUBSTANTIALLY EQUIVALENT	1
COCHLEAR AMERICAS
	SUBSTANTIALLY EQUIVALENT	11
COCHLEAR BONE ANCHORED SYSTEMS AB
	SUBSTANTIALLY EQUIVALENT	1
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
	SUBSTANTIALLY EQUIVALENT	1
OTICON MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	7
SONITUS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
SONITUS MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
SOPHONO INC.
	SUBSTANTIALLY EQUIVALENT	1
SOPHONO, INC
	SUBSTANTIALLY EQUIVALENT	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Term/Code Not Available	3140	3140
Loss of Osseointegration	821	821
Adverse Event Without Identified Device or Use Problem	478	478
Patient Device Interaction Problem	380	380
Insufficient Information	191	191
Failure to Osseointegrate	76	76
Expulsion	43	43
Patient-Device Incompatibility	20	20
Biocompatibility	20	20
Extrusion	17	17
Inadequacy of Device Shape and/or Size	16	16
No Apparent Adverse Event	11	11
Osseointegration Problem	10	10
Device Appears to Trigger Rejection	7	7
Loosening of Implant Not Related to Bone-Ingrowth	7	7
Signal Artifact/Noise	6	6
Output Problem	6	6
Device Dislodged or Dislocated	5	5
Improper or Incorrect Procedure or Method	5	5
Therapeutic or Diagnostic Output Failure	4	4
Battery Problem	4	4
Use of Device Problem	4	4
Missing Value Reason	4	4
Device Operates Differently Than Expected	4	4
Migration	3	3
Migration or Expulsion of Device	3	3
Unexpected Therapeutic Results	2	2
Defective Component	2	2
Material Integrity Problem	2	2
Misassembly During Maintenance/Repair	2	2
Thermal Decomposition of Device	2	2
Detachment of Device or Device Component	2	2
Contamination	2	2
Loose or Intermittent Connection	2	2
Failure to Deliver Shock/Stimulation	2	2
Unintended Movement	1	1
Break	1	1
Malposition of Device	1	1
Device Issue	1	1
Device Inoperable	1	1
Overheating of Device	1	1
Noise, Audible	1	1
Labelling, Instructions for Use or Training Problem	1	1
Material Protrusion/Extrusion	1	1
Device Handling Problem	1	1
Component Missing	1	1
Disconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	708	708
Unspecified Infection	662	662
Bacterial Infection	639	639
No Information	592	592
Pain	429	429
Patient Problem/Medical Problem	359	359
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	337	337
No Clinical Signs, Symptoms or Conditions	251	251
Host-Tissue Reaction	240	240
Skin Infection	174	174
Inadequate Osseointegration	159	159
Impaired Healing	151	151
Hearing Impairment	149	149
Head Injury	107	107
Swelling	81	81
Tissue Breakdown	79	79
Insufficient Information	75	75
Skin Inflammation/ Irritation	72	72
Inflammation	69	69
Discomfort	67	67
Cellulitis	49	49
Implant Pain	46	46
Skin Irritation	45	45
Deafness	43	43
Headache	40	40
Purulent Discharge	28	28
Necrosis Of Flap Tissue	27	27
Scar Tissue	27	27
Necrosis	23	23
Wound Dehiscence	21	21
Fluid Discharge	21	21
Hematoma	19	19
Post Operative Wound Infection	18	18
Irritation	18	18
Swelling/ Edema	15	15
Erythema	15	15
Skin Disorders	11	11
Foreign Body Reaction	11	11
Abscess	9	9
Seroma	9	9
Discharge	8	8
No Consequences Or Impact To Patient	8	8
No Known Impact Or Consequence To Patient	7	7
Dizziness	7	7
Skin Inflammation	7	7
Hemorrhage/Bleeding	6	6
Pressure Sores	6	6
Skin Erosion	6	6
Failure of Implant	6	6
Staphylococcus Aureus	5	5