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
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	776	776
Adverse Event Without Identified Device or Use Problem	688	688
Fracture	343	343
Device-Device Incompatibility	163	163
Material Twisted/Bent	153	153
Migration	97	97
Device Slipped	94	94
Material Deformation	90	90
Manufacturing, Packaging or Shipping Problem	61	61
Loosening of Implant Not Related to Bone-Ingrowth	53	53
Entrapment of Device	41	41
Crack	40	40
Difficult to Advance	31	31
Osseointegration Problem	26	26
Migration or Expulsion of Device	26	26
Defective Device	19	19
Failure to Cut	17	17
Device Appears to Trigger Rejection	16	16
Patient-Device Incompatibility	16	16
Material Integrity Problem	16	16
Patient Device Interaction Problem	16	16
Device Dislodged or Dislocated	15	15
No Apparent Adverse Event	15	15
Device Damaged Prior to Use	15	15
Loss of Osseointegration	14	14
Insufficient Information	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
Difficult to Insert	8	8
Nonstandard Device	7	7
Use of Device Problem	6	6
Failure to Osseointegrate	5	5
Output Problem	5	5
Positioning Problem	4	4
Component Missing	4	4
Device Markings/Labelling Problem	4	4
Dull, Blunt	4	4
Material Frayed	4	4
Difficult or Delayed Positioning	3	3
Tear, Rip or Hole in Device Packaging	3	3
Device Contamination with Body Fluid	3	3
Appropriate Term/Code Not Available	3	3
Improper or Incorrect Procedure or Method	3	3
Mechanical Jam	3	3
Device Contaminated During Manufacture or Shipping	3	3
Biocompatibility	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1008	1008
No Consequences Or Impact To Patient	246	246
Unspecified Infection	240	240
Insufficient Information	171	171
Failure of Implant	150	150
Pain	141	141
Non-union Bone Fracture	125	125
No Code Available	120	120
Foreign Body In Patient	104	104
Impaired Healing	85	85
Swelling/ Edema	75	75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
No Known Impact Or Consequence To Patient	64	64
Unspecified Tissue Injury	64	64
Wound Dehiscence	32	32
Nerve Damage	31	31
Physical Asymmetry	30	30
Discomfort	28	28
No Patient Involvement	28	28
No Information	26	26
Inflammation	26	26
Bacterial Infection	23	23
Post Operative Wound Infection	22	22
Confusion/ Disorientation	21	21
Difficulty Chewing	20	20
Inadequate Osseointegration	20	20
Hypersensitivity/Allergic reaction	17	17
Purulent Discharge	16	16
Erythema	14	14
Loss of Range of Motion	14	14
Bone Fracture(s)	14	14
Skin Inflammation/ Irritation	14	14
Cerebrospinal Fluid Leakage	14	14
Headache	14	14
Swelling	13	13
Inadequate Pain Relief	13	13
Limited Mobility Of The Implanted Joint	12	12
Implant Pain	11	11
Paralysis	11	11
Paresthesia	10	10
Necrosis	9	9
Fluid Discharge	8	8
Osteolysis	8	8
Foreign Body Reaction	8	8
Device Embedded In Tissue or Plaque	8	8
Obstruction/Occlusion	6	6
Difficulty Chewing	6	6
Abscess	5	5
Facial Nerve Paralysis	5	5
Eye Pain	5	5