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	1
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	1639	1639
Break	647	647
Device-Device Incompatibility	392	392
Migration	379	380
Fracture	152	152
Material Twisted/Bent	72	72
Mechanical Problem	57	57
Material Deformation	49	49
Insufficient Information	48	48
Use of Device Problem	45	45
Manufacturing, Packaging or Shipping Problem	44	44
Mechanical Jam	42	42
Device Slipped	34	34
Appropriate Term/Code Not Available	33	33
Crack	28	28
No Apparent Adverse Event	25	25
Defective Device	24	24
Entrapment of Device	22	22
Migration or Expulsion of Device	22	22
Loosening of Implant Not Related to Bone-Ingrowth	19	19
Corroded	19	19
Detachment of Device or Device Component	18	18
Device Contaminated During Manufacture or Shipping	14	14
Physical Resistance/Sticking	14	14
Loss of Osseointegration	13	13
Difficult to Advance	12	12
Material Integrity Problem	12	12
Mechanics Altered	10	10
Connection Problem	9	9
Unintended Movement	8	8
Positioning Failure	8	8
Unintended System Motion	7	7
Naturally Worn	7	7
Improper or Incorrect Procedure or Method	6	6
Failure to Osseointegrate	6	6
Material Separation	5	5
Failure to Cut	5	5
Off-Label Use	5	5
Device Difficult to Setup or Prepare	5	5
Material Fragmentation	5	5
Material Discolored	4	4
Degraded	4	4
Patient Device Interaction Problem	4	4
Incomplete or Inadequate Connection	4	4
Device Damaged Prior to Use	4	4
Component Missing	3	3
Loose or Intermittent Connection	3	3
Contamination /Decontamination Problem	3	3
Device Markings/Labelling Problem	3	3
Malposition of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	881	881
Non-union Bone Fracture	475	475
No Code Available	397	397
Pain	362	362
Failure of Implant	326	326
Insufficient Information	297	298
Bone Fracture(s)	271	271
Necrosis	233	233
Unspecified Infection	220	220
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	214	214
Post Operative Wound Infection	150	150
Physical Asymmetry	125	125
Injury	108	108
No Consequences Or Impact To Patient	85	85
Malunion of Bone	58	58
Loss of Range of Motion	50	50
Fall	48	48
Unspecified Tissue Injury	47	47
No Known Impact Or Consequence To Patient	43	43
No Patient Involvement	40	40
Limb Fracture	34	34
Foreign Body In Patient	32	32
Impaired Healing	27	27
Hypersensitivity/Allergic reaction	24	24
Discomfort	24	24
Swelling/ Edema	23	23
Nerve Damage	23	23
Joint Dislocation	23	23
Deformity/ Disfigurement	20	20
Hematoma	19	19
Ambulation Difficulties	19	19
Implant Pain	15	15
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
Inflammation	7	7
Fistula	7	7
Hemorrhage/Bleeding	7	7
Death	7	7
Skin Inflammation/ Irritation	6	6
Device Embedded In Tissue or Plaque	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Wound Dehiscence	4	4
Cyst(s)	4	4
Joint Laxity	4	4
Muscular Rigidity	4	4