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
INION OY
	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
MONTJADE ENGINEERING CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
REOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1
SITES MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
1. K213777 Stryker Resorbable Fixation System
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
1. K213777 Stryker Resorbable Fixation System
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
TECHMAH CMF
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1315	1315
Adverse Event Without Identified Device or Use Problem	723	723
Fracture	385	385
Device-Device Incompatibility	171	171
Material Twisted/Bent	156	156
Material Deformation	110	110
Migration	104	104
Device Slipped	103	103
Manufacturing, Packaging or Shipping Problem	88	88
Device Contaminated During Manufacture or Shipping	73	73
Entrapment of Device	64	64
No Apparent Adverse Event	57	57
Crack	48	48
Loosening of Implant Not Related to Bone-Ingrowth	47	47
Difficult to Advance	31	31
Osseointegration Problem	30	30
Device Appears to Trigger Rejection	27	27
Migration or Expulsion of Device	26	26
Failure to Cut	22	22
Defective Device	20	20
Inadequacy of Device Shape and/or Size	18	18
Patient Device Interaction Problem	17	17
Patient-Device Incompatibility	16	16
Material Integrity Problem	16	16
Loss of Osseointegration	15	15
Device Damaged Prior to Use	15	15
Device Dislodged or Dislocated	15	15
Insufficient Information	14	14
Nonstandard Device	12	12
Material Fragmentation	12	12
Noise, Audible	11	11
Packaging Problem	11	11
Use of Device Problem	10	10
Malposition of Device	10	10
Detachment of Device or Device Component	9	9
Material Discolored	8	8
Difficult to Insert	8	8
Failure to Osseointegrate	5	5
Output Problem	5	5
Component Missing	4	4
Positioning Problem	4	4
Device Markings/Labelling Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Dull, Blunt	4	4
Positioning Failure	3	3
Difficult or Delayed Positioning	3	3
Tear, Rip or Hole in Device Packaging	3	3
Appropriate Term/Code Not Available	3	3
Naturally Worn	3	3
Mechanical Jam	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1715	1715
Unspecified Infection	252	252
No Consequences Or Impact To Patient	246	246
Insufficient Information	205	205
Failure of Implant	151	151
Pain	149	149
Non-union Bone Fracture	138	138
Foreign Body In Patient	127	127
No Code Available	120	120
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	38	38
Wound Dehiscence	32	32
Nerve Damage	32	32
Discomfort	29	29
No Patient Involvement	28	28
Inflammation	27	27
No Information	26	26
Inadequate Osseointegration	24	24
Post Operative Wound Infection	24	24
Difficulty Chewing	23	23
Bacterial Infection	23	23
Confusion/ Disorientation	21	21
Hypersensitivity/Allergic reaction	18	18
Purulent Discharge	16	16
Bone Fracture(s)	15	15
Headache	14	14
Cerebrospinal Fluid Leakage	14	14
Loss of Range of Motion	14	14
Erythema	14	14
Skin Inflammation/ Irritation	14	14
Inadequate Pain Relief	13	13
Swelling	13	13
Implant Pain	12	12
Limited Mobility Of The Implanted Joint	12	12
Obstruction/Occlusion	11	11
Paralysis	11	11
Necrosis	10	10
Paresthesia	10	10
Fluid Discharge	8	8
Device Embedded In Tissue or Plaque	8	8
Foreign Body Reaction	8	8
Visual Disturbances	8	8
Malunion of Bone	7	7
Fistula	7	7
Deformity/ Disfigurement	6	6
Difficulty Chewing	6	6