TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BHM-TECH PRODUKTIONSGESELLSCHAFT MBH
	SUBSTANTIALLY EQUIVALENT	1
COCHLEAR
	SUBSTANTIALLY EQUIVALENT	1
COCHLEAR AMERICAS
	SUBSTANTIALLY EQUIVALENT	2
OTICON MEDICAL AB
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN MAGNET TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ZDEER TECHNOLOGY (HENAN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Appropriate Device Problem Term/Code Not Available	675	685
Patient Device Interaction Problem	567	581
Adverse Event Without Identified Device or Use Problem	273	274
Loss of Osseointegration	198	200
Insufficient Device Problem Information	54	55
Expulsion	49	50
Therapeutic or Diagnostic Output Failure	26	26
Inadequacy of Device Shape and/or Size	25	25
Signal Artifact/Noise	23	23
No Apparent Adverse Event	16	17
Output Problem	11	11
Unexpected Therapeutic Results	11	11
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Patient-Device Incompatibility	9	9
Failure to Osseointegrate	9	9
Detachment of Device or Device Component	7	7
Device Appears to Trigger Rejection	5	5
Device Dislodged or Dislocated	3	3
Fail-Safe Did Not Operate	2	2
Failure to Deliver Shock/Stimulation	2	2
Explosion	2	2
Device Handling Problem	2	2
Misassembly During Maintenance/Repair	2	2
Biocompatibility	2	2
Noise, Audible	1	1
Battery Problem	1	1
Overheating of Device	1	1
Migration or Expulsion of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	382	382
No Clinical Signs, Symptoms or Conditions	318	321
Skin Infection	247	254
Unspecified Infection	183	189
Inadequate Osseointegration	181	183
Impaired Healing	163	165
Pain	140	144
Insufficient Information	81	81
Skin Inflammation/ Irritation	74	74
Tissue Breakdown	71	72
Discomfort	68	68
Implant Pain	59	59
Head Injury	31	31
Cellulitis	23	25
Headache	21	21
Purulent Discharge	18	20
Swelling/ Edema	17	21
Necrosis	17	17
Erythema	16	18
Bacterial Infection	15	15
Scar Tissue	13	13
Fluid Discharge	12	13
Wound Dehiscence	10	10
Hemorrhage/Blood Loss/Bleeding	10	10
Skin Burning Sensation	6	6
Hearing Impairment	6	6
Post Operative Wound Infection	6	6
Hematoma	4	4
Inflammation	4	4
Tinnitus	4	4
Ulcer	4	4
Skin Erosion	4	4
Burning Sensation	4	4
Drug Resistant Bacterial Infection	4	4
Fistula	3	3
Medical device site infection	3	3
Pressure Sore/Ulcer	3	3
Dizziness	3	3
Medical Device Site Inflammation	2	2
Fall	2	2
Failure of Implant	2	2
Itching Sensation	2	2
Osteomyelitis	2	2
Abnormal scarring	2	2
Hyperresponsive to stimuli	2	2
Balance Problems	2	2
Seroma	2	2
Blister	2	2
Electric Shock	2	2
Solid Tumour	2	2