TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	1
DELPHOS IMPLANTS - IND.COM. IMPORTACAO E EXPORTACAO DE
	SUBSTANTIALLY EQUIVALENT	1
FAICO MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	3
MCI MEDICAL CONCEPT INNOVATION INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDCAD
	SUBSTANTIALLY EQUIVALENT	2
METICULY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MONTJADE ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SITES MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	4
STRYKER CRANIOMAXILLOFACIAL
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CRANIOMAXILLOFACIAL (CMF)
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	3
STRYKER LEIBINGER MICRO IMPLANTS
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
TECHMAH CMF
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	850	850
Break	772	772
Fracture	351	351
Device-Device Incompatibility	157	157
Device Slipped	107	107
Material Deformation	99	99
Material Twisted/Bent	98	98
Migration	94	94
Loosening of Implant Not Related to Bone-Ingrowth	50	50
Manufacturing, Packaging or Shipping Problem	47	47
Insufficient Information	43	43
No Apparent Adverse Event	42	42
Entrapment of Device	36	36
Crack	36	36
Difficult to Advance	33	33
Osseointegration Problem	32	32
Device Appears to Trigger Rejection	31	31
Migration or Expulsion of Device	27	27
Patient Device Interaction Problem	23	23
Patient-Device Incompatibility	21	21
Defective Device	21	21
Device Dislodged or Dislocated	20	20
Inadequacy of Device Shape and/or Size	17	17
Failure to Cut	17	17
Material Integrity Problem	16	16
Material Fragmentation	15	15
Unintended Movement	15	15
Device Damaged Prior to Use	13	13
Loss of Osseointegration	12	12
Detachment of Device or Device Component	12	12
Packaging Problem	11	11
Difficult to Insert	11	11
Noise, Audible	10	10
Use of Device Problem	8	8
Malposition of Device	8	8
Appropriate Term/Code Not Available	7	7
Nonstandard Device	7	7
Device Markings/Labelling Problem	6	6
Dull, Blunt	6	6
Component Missing	5	5
Output Problem	5	5
Naturally Worn	5	5
Material Frayed	4	4
Positioning Problem	4	4
Tear, Rip or Hole in Device Packaging	4	4
Improper or Incorrect Procedure or Method	4	4
Biocompatibility	3	3
Failure to Osseointegrate	3	3
Physical Resistance/Sticking	3	3
Device Contaminated During Manufacture or Shipping	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	768	768
Unspecified Infection	408	408
No Consequences Or Impact To Patient	343	343
No Code Available	341	341
Failure of Implant	180	180
Pain	151	151
Impaired Healing	144	144
Non-union Bone Fracture	142	142
Insufficient Information	141	141
Foreign Body In Patient	120	120
No Known Impact Or Consequence To Patient	96	96
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
Swelling/ Edema	71	71
Unspecified Tissue Injury	57	57
Erosion	55	55
Bone Fracture(s)	47	47
No Patient Involvement	43	43
No Information	38	38
Wound Dehiscence	32	32
Discomfort	29	29
Hypersensitivity/Allergic reaction	28	28
Purulent Discharge	26	26
Inflammation	25	25
Bacterial Infection	24	24
Nerve Damage	22	22
Post Operative Wound Infection	22	22
Physical Asymmetry	21	21
Confusion/ Disorientation	21	21
Difficulty Chewing	19	19
Swelling	18	18
Loss of Range of Motion	18	18
Device Embedded In Tissue or Plaque	17	17
Injury	17	17
Headache	16	16
Inadequate Osseointegration	15	15
Skin Inflammation/ Irritation	14	14
Limited Mobility Of The Implanted Joint	13	13
Inadequate Pain Relief	13	13
Cerebrospinal Fluid Leakage	13	13
Skin Irritation	12	12
Reaction	11	11
Implant Pain	11	11
Difficulty Chewing	10	10
Necrosis	9	9
Hematoma	9	9
Ossification	9	9
Osteolysis	8	8
Fluid Discharge	8	8
Foreign Body Reaction	8	8
Scar Tissue	7	7