TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	1
FAICO MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S.
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	2
MEDCAD
	SUBSTANTIALLY EQUIVALENT	2
METICULY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K220360 Tandry CMF Plate System
MONTJADE ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SITES MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
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
TECHMAH CMF
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	940	940
Adverse Event Without Identified Device or Use Problem	700	700
Fracture	358	358
Device-Device Incompatibility	170	170
Material Twisted/Bent	153	153
Material Deformation	100	100
Migration	99	99
Device Slipped	94	94
Manufacturing, Packaging or Shipping Problem	63	63
Loosening of Implant Not Related to Bone-Ingrowth	53	53
Entrapment of Device	45	45
Crack	41	41
Difficult to Advance	31	31
Osseointegration Problem	29	29
Migration or Expulsion of Device	26	26
Defective Device	19	19
Device Appears to Trigger Rejection	18	18
Device Dislodged or Dislocated	17	17
Failure to Cut	17	17
Patient Device Interaction Problem	16	16
Patient-Device Incompatibility	16	16
Material Integrity Problem	16	16
No Apparent Adverse Event	15	15
Device Damaged Prior to Use	15	15
Insufficient Information	14	14
Loss of Osseointegration	14	14
Inadequacy of Device Shape and/or Size	13	13
Detachment of Device or Device Component	12	12
Material Fragmentation	12	12
Noise, Audible	11	11
Packaging Problem	11	11
Malposition of Device	10	10
Use of Device Problem	9	9
Difficult to Insert	8	8
Nonstandard Device	7	7
Output Problem	5	5
Failure to Osseointegrate	5	5
Dull, Blunt	4	4
Material Frayed	4	4
Component Missing	4	4
Device Markings/Labelling Problem	4	4
Positioning Problem	4	4
Difficult or Delayed Positioning	3	3
Device Contamination with Body Fluid	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Contaminated During Manufacture or Shipping	3	3
Appropriate Term/Code Not Available	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Jam	3	3
Biocompatibility	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1186	1186
No Consequences Or Impact To Patient	246	246
Unspecified Infection	242	242
Insufficient Information	180	180
Failure of Implant	151	151
Pain	145	145
Non-union Bone Fracture	129	129
No Code Available	120	120
Foreign Body In Patient	108	108
Impaired Healing	85	85
Swelling/ Edema	75	75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
Unspecified Tissue Injury	70	70
No Known Impact Or Consequence To Patient	64	64
Physical Asymmetry	33	33
Wound Dehiscence	32	32
Nerve Damage	32	32
Discomfort	28	28
No Patient Involvement	28	28
Inflammation	26	26
No Information	26	26
Post Operative Wound Infection	23	23
Bacterial Infection	23	23
Inadequate Osseointegration	23	23
Confusion/ Disorientation	21	21
Difficulty Chewing	21	21
Hypersensitivity/Allergic reaction	17	17
Purulent Discharge	16	16
Skin Inflammation/ Irritation	14	14
Bone Fracture(s)	14	14
Cerebrospinal Fluid Leakage	14	14
Headache	14	14
Loss of Range of Motion	14	14
Erythema	14	14
Swelling	13	13
Inadequate Pain Relief	13	13
Limited Mobility Of The Implanted Joint	12	12
Implant Pain	11	11
Osteolysis	11	11
Paralysis	11	11
Paresthesia	10	10
Necrosis	9	9
Fluid Discharge	8	8
Visual Disturbances	8	8
Foreign Body Reaction	8	8
Device Embedded In Tissue or Plaque	8	8
Deformity/ Disfigurement	6	6
Difficulty Chewing	6	6
Fistula	6	6
Obstruction/Occlusion	6	6