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	918	918
Break	890	890
Fracture	374	374
Device-Device Incompatibility	180	180
Material Twisted/Bent	160	160
Device Slipped	127	127
Migration	102	102
Material Deformation	101	101
Loosening of Implant Not Related to Bone-Ingrowth	54	54
Manufacturing, Packaging or Shipping Problem	53	53
No Apparent Adverse Event	47	47
Insufficient Information	45	45
Crack	41	41
Entrapment of Device	39	39
Difficult to Advance	33	33
Osseointegration Problem	32	32
Device Appears to Trigger Rejection	31	31
Migration or Expulsion of Device	28	28
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	19	19
Failure to Cut	17	17
Material Integrity Problem	16	16
Loss of Osseointegration	15	15
Material Fragmentation	15	15
Device Damaged Prior to Use	15	15
Unintended Movement	15	15
Noise, Audible	14	14
Detachment of Device or Device Component	12	12
Difficult to Insert	11	11
Malposition of Device	11	11
Packaging Problem	11	11
Use of Device Problem	8	8
Nonstandard Device	7	7
Appropriate Term/Code Not Available	7	7
Dull, Blunt	6	6
Device Markings/Labelling Problem	6	6
Naturally Worn	5	5
Component Missing	5	5
Failure to Osseointegrate	5	5
Output Problem	5	5
Material Frayed	4	4
Positioning Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Tear, Rip or Hole in Device Packaging	4	4
Biocompatibility	3	3
Device Contaminated During Manufacture or Shipping	3	3
Mechanical Jam	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	967	967
Unspecified Infection	428	428
No Consequences Or Impact To Patient	343	343
No Code Available	341	341
Failure of Implant	189	189
Pain	171	171
Insufficient Information	167	167
Impaired Healing	146	146
Non-union Bone Fracture	145	145
Foreign Body In Patient	126	126
No Known Impact Or Consequence To Patient	96	96
Swelling/ Edema	75	75
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	73	73
Unspecified Tissue Injury	61	61
Erosion	55	55
Bone Fracture(s)	48	48
No Patient Involvement	43	43
No Information	38	38
Nerve Damage	35	35
Wound Dehiscence	32	32
Discomfort	31	31
Physical Asymmetry	30	30
Hypersensitivity/Allergic reaction	29	29
Purulent Discharge	26	26
Inflammation	25	25
Bacterial Infection	24	24
Post Operative Wound Infection	23	23
Confusion/ Disorientation	21	21
Difficulty Chewing	20	20
Inadequate Osseointegration	20	20
Swelling	18	18
Loss of Range of Motion	18	18
Injury	17	17
Device Embedded In Tissue or Plaque	17	17
Headache	16	16
Skin Inflammation/ Irritation	14	14
Erythema	14	14
Cerebrospinal Fluid Leakage	14	14
Inadequate Pain Relief	13	13
Limited Mobility Of The Implanted Joint	13	13
Skin Irritation	12	12
Implant Pain	11	11
Reaction	11	11
Paralysis	11	11
Necrosis	10	10
Paresthesia	10	10
Difficulty Chewing	10	10
Hematoma	9	9
Ossification	9	9
Fluid Discharge	8	8