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
AMDT HOLDINGS, INC
	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	4
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	1944	1944
Break	707	707
Device-Device Incompatibility	431	431
Migration	400	401
Fracture	176	176
Material Twisted/Bent	82	82
Mechanical Problem	64	64
Material Deformation	51	51
Insufficient Information	50	50
Use of Device Problem	49	49
Mechanical Jam	44	44
Manufacturing, Packaging or Shipping Problem	44	44
Crack	41	41
Device Slipped	40	40
Appropriate Term/Code Not Available	35	35
Detachment of Device or Device Component	31	31
No Apparent Adverse Event	28	28
Defective Device	25	25
Corroded	22	22
Entrapment of Device	22	22
Migration or Expulsion of Device	22	22
Loosening of Implant Not Related to Bone-Ingrowth	20	20
Device Contaminated During Manufacture or Shipping	14	14
Physical Resistance/Sticking	14	14
Loss of Osseointegration	13	13
Difficult to Advance	13	13
Material Integrity Problem	12	12
Mechanics Altered	11	11
Contamination /Decontamination Problem	11	11
Connection Problem	9	9
Positioning Failure	9	9
Unintended Movement	8	8
Naturally Worn	7	7
Unintended System Motion	7	7
Improper or Incorrect Procedure or Method	6	6
Material Fragmentation	6	6
Off-Label Use	6	6
Failure to Osseointegrate	6	6
Device Difficult to Setup or Prepare	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
Difficult to Remove	3	3
Loose or Intermittent Connection	3	3
Component Missing	3	3
Malposition of Device	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1008	1008
Non-union Bone Fracture	498	498
Pain	435	435
No Code Available	397	397
Insufficient Information	381	382
Failure of Implant	338	338
Bone Fracture(s)	277	277
Necrosis	244	244
Unspecified Infection	221	221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	216	216
Post Operative Wound Infection	159	159
Physical Asymmetry	126	126
Injury	108	108
Malunion of Bone	96	96
No Consequences Or Impact To Patient	85	85
Osteomyelitis	70	70
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	24	24
Nerve Damage	23	23
Joint Dislocation	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	12	12
Metal Related Pathology	10	10
Bacterial Infection	9	9
Foreign Body Embolism	9	9
Hemorrhage/Bleeding	8	8
Inflammation	7	7
Skin Inflammation/ Irritation	7	7
Fistula	7	7
Death	7	7
Wound Dehiscence	6	6
Joint Laxity	5	5
Cramp(s) /Muscle Spasm(s)	4	4
Cyst(s)	4	4
Foreign Body Reaction	4	4