TPLC - Total Product Life Cycle

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Device	appliance, fixation, nail/blade/plate combination, multiple component
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	KTT
Regulation Number	888.3030
Device Class	2

Premarket Reviews
Manufacturer	Decision
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ARROWHEAD DE, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
GLW MEDICAL INNOVATION
	SUBSTANTIALLY EQUIVALENT	1
METRIC MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEW STANDARD DEVICE DBA METALOGIX
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	1
ORTHONOVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	3
ORTHOSPIN LTD
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	2
RESPONSE ORTHO SOLUTIONS LLC
	SUBSTANTIALLY EQUIVALENT	1
S H PITKAR ORTHOTOOLS PVT LTD
	SUBSTANTIALLY EQUIVALENT	1
S H PITKAR ORTHOTOOLS PVT LTD.
	SUBSTANTIALLY EQUIVALENT	1
SEQUEL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
VILEX LLC
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WISHBONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1895	1895
Break	653	653
Device-Device Incompatibility	401	401
Migration	393	394
Fracture	160	160
Material Twisted/Bent	75	75
Mechanical Problem	57	57
Material Deformation	50	50
Use of Device Problem	48	48
Insufficient Information	48	48
Manufacturing, Packaging or Shipping Problem	44	44
Mechanical Jam	43	43
Device Slipped	35	35
Appropriate Term/Code Not Available	33	33
Crack	30	30
No Apparent Adverse Event	27	27
Defective Device	24	24
Entrapment of Device	22	22
Migration or Expulsion of Device	22	22
Detachment of Device or Device Component	21	21
Corroded	19	19
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Device Contaminated During Manufacture or Shipping	14	14
Physical Resistance/Sticking	14	14
Difficult to Advance	13	13
Loss of Osseointegration	13	13
Material Integrity Problem	12	12
Mechanics Altered	11	11
Connection Problem	9	9
Unintended Movement	8	8
Positioning Failure	8	8
Unintended System Motion	7	7
Naturally Worn	7	7
Failure to Osseointegrate	6	6
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	5	5
Device Difficult to Setup or Prepare	5	5
Off-Label Use	5	5
Failure to Cut	5	5
Material Separation	5	5
Patient Device Interaction Problem	4	4
Degraded	4	4
Material Discolored	4	4
Incomplete or Inadequate Connection	4	4
Device Damaged Prior to Use	4	4
Loose or Intermittent Connection	3	3
Contamination /Decontamination Problem	3	3
Component Missing	3	3
Device Markings/Labelling Problem	3	3
Difficult to Remove	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	914	914
Non-union Bone Fracture	490	490
Pain	432	432
No Code Available	397	397
Insufficient Information	358	359
Failure of Implant	337	337
Bone Fracture(s)	271	271
Necrosis	235	235
Unspecified Infection	221	221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	214	214
Post Operative Wound Infection	159	159
Physical Asymmetry	125	125
Injury	108	108
No Consequences Or Impact To Patient	85	85
Osteomyelitis	70	70
Malunion of Bone	68	68
Loss of Range of Motion	52	52
Fall	52	52
Unspecified Tissue Injury	49	49
No Known Impact Or Consequence To Patient	43	43
No Patient Involvement	40	40
Impaired Healing	36	36
Limb Fracture	34	34
Foreign Body In Patient	32	32
Hypersensitivity/Allergic reaction	25	25
Discomfort	24	24
Swelling/ Edema	23	23
Joint Dislocation	23	23
Nerve Damage	23	23
Implant Pain	21	21
Deformity/ Disfigurement	20	20
Hematoma	20	20
Ambulation Difficulties	19	19
Arthritis	15	15
Fluid Discharge	14	14
Thrombosis/Thrombus	13	13
Sepsis	11	11
Metal Related Pathology	10	10
Bacterial Infection	9	9
Foreign Body Embolism	9	9
Hemorrhage/Bleeding	8	8
Inflammation	7	7
Death	7	7
Fistula	7	7
Skin Inflammation/ Irritation	6	6
Wound Dehiscence	6	6
Joint Laxity	4	4
Device Embedded In Tissue or Plaque	4	4
Muscular Rigidity	4	4
Cyst(s)	4	4