TPLC - Total Product Life Cycle

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Device	appliance, fixation, nail/blade/plate combination, multiple component
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	2
ARTHREX INC
	SUBSTANTIALLY EQUIVALENT	1
AUSTIN MILLER TRAUMA LLC
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
GLW MEDICAL INNOVATION
	SUBSTANTIALLY EQUIVALENT	1
METRIC MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEW STANDARD DEVICE DBA METALOGIX
	SUBSTANTIALLY EQUIVALENT	2
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	1
ORTHONOVIS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	2
ORTHOPEDIATRICS CORP.
	SUBSTANTIALLY EQUIVALENT	2
ORTHOSPIN
	SUBSTANTIALLY EQUIVALENT	1
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	2
SEQUEL MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	3
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	1838	1838
Break	748	748
Migration	465	466
Device-Device Incompatibility	448	448
Fracture	169	169
Material Twisted/Bent	97	97
Mechanical Problem	72	72
Material Deformation	61	61
Insufficient Information	57	57
Device Slipped	55	55
No Apparent Adverse Event	54	54
Migration or Expulsion of Device	48	48
Use of Device Problem	47	47
Manufacturing, Packaging or Shipping Problem	45	45
Mechanical Jam	44	44
Appropriate Term/Code Not Available	42	42
Loosening of Implant Not Related to Bone-Ingrowth	24	24
Crack	24	24
Detachment of Device or Device Component	23	23
Defective Device	23	23
Entrapment of Device	22	22
Corroded	19	19
Loss of Osseointegration	16	16
Physical Resistance/Sticking	14	14
Difficult to Advance	13	13
Material Integrity Problem	12	12
Unintended Movement	11	11
Mechanics Altered	10	10
Improper or Incorrect Procedure or Method	10	10
Connection Problem	9	9
Device Contaminated During Manufacture or Shipping	9	9
Naturally Worn	8	8
Positioning Failure	8	8
Unintended System Motion	7	7
Device Dislodged or Dislocated	6	6
Material Fragmentation	6	6
Failure to Osseointegrate	6	6
Off-Label Use	5	5
Material Separation	5	5
Failure to Cut	5	5
Material Discolored	5	5
Device Difficult to Setup or Prepare	5	5
Loose or Intermittent Connection	5	5
Patient-Device Incompatibility	4	4
Device Damaged Prior to Use	4	4
Incomplete or Inadequate Connection	4	4
Difficult or Delayed Positioning	4	4
Difficult to Remove	4	4
Patient Device Interaction Problem	4	4
Degraded	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	843	843
No Code Available	771	771
Non-union Bone Fracture	455	455
Pain	442	442
Failure of Implant	367	367
Bone Fracture(s)	362	362
Unspecified Infection	267	267
Insufficient Information	260	261
Necrosis	251	251
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	214	214
No Consequences Or Impact To Patient	164	164
Post Operative Wound Infection	148	148
Injury	146	146
Physical Asymmetry	125	125
No Patient Involvement	85	85
No Known Impact Or Consequence To Patient	80	80
Impaired Healing	61	61
Malunion of Bone	54	54
Loss of Range of Motion	52	52
Fall	51	51
Unspecified Tissue Injury	44	44
Discomfort	37	37
Foreign Body In Patient	36	36
Limb Fracture	34	34
Deformity/ Disfigurement	30	30
Hypersensitivity/Allergic reaction	27	27
Joint Dislocation	25	25
Nerve Damage	23	23
Hematoma	22	22
Swelling/ Edema	22	22
Ambulation Difficulties	18	18
Arthritis	17	17
Wound Dehiscence	16	16
Implant Pain	14	14
Fluid Discharge	13	13
Sepsis	12	12
Thrombosis/Thrombus	12	12
No Information	11	11
Reaction	11	11
Blood Loss	10	10
Metal Related Pathology	9	9
Inflammation	9	9
Foreign Body Embolism	9	9
Bacterial Infection	9	9
Skin Erosion	9	9
Device Embedded In Tissue or Plaque	8	8
Hemorrhage/Bleeding	7	7
Fistula	7	7
Death	7	7
Skin Inflammation/ Irritation	6	6