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
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BLUE OCEAN GLOBAL
	SUBSTANTIALLY EQUIVALENT	1
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
MEDUSA ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
METRIC MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
NEW STANDARD DEVICE DBA METALOGIX
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	2
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	6
RESPONSE ORTHO SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	2
SEQUEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	1
STABILIZ ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	3
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	1
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	2
WISHBONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1577	1593
Break	597	602
Device-Device Incompatibility	363	370
Migration	351	361
Fracture	178	178
Material Twisted/Bent	76	76
Crack	64	64
Mechanical Problem	50	50
Use of Device Problem	45	45
Material Deformation	44	44
Manufacturing, Packaging or Shipping Problem	44	44
Device Slipped	38	38
Detachment of Device or Device Component	32	32
Mechanical Jam	31	31
No Apparent Adverse Event	27	28
Entrapment of Device	22	22
Insufficient Information	22	22
Corroded	20	20
Appropriate Term/Code Not Available	18	18
Defective Device	18	18
Device Contaminated During Manufacture or Shipping	14	14
Physical Resistance/Sticking	14	14
Material Integrity Problem	14	14
Difficult to Advance	13	14
Mechanics Altered	11	11
Contamination /Decontamination Problem	11	12
Loosening of Implant Not Related to Bone-Ingrowth	10	10
Connection Problem	7	7
Unintended System Motion	7	7
Off-Label Use	6	6
Positioning Failure	6	6
Improper or Incorrect Procedure or Method	5	5
Naturally Worn	4	5
Device Damaged Prior to Use	4	4
Material Discolored	4	4
Material Fragmentation	4	5
Material Separation	3	3
Component Missing	3	3
Degraded	3	3
Unintended Movement	3	3
Device Markings/Labelling Problem	3	3
Malposition of Device	3	3
Migration or Expulsion of Device	3	3
Difficult to Remove	2	2
Failure to Cut	2	2
Unclear Information	2	2
Collapse	2	2
Incomplete or Inadequate Connection	2	2
Inaccurate Information	2	2
Unstable	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1050	1059
Insufficient Information	428	441
Non-union Bone Fracture	411	411
Pain	354	355
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	208	208
Necrosis	208	210
Failure of Implant	203	204
Bone Fracture(s)	188	191
Unspecified Infection	166	167
Post Operative Wound Infection	130	131
Physical Asymmetry	128	130
Malunion of Bone	96	96
Osteomyelitis	70	70
Fall	54	56
Unspecified Tissue Injury	48	48
Loss of Range of Motion	38	38
Limb Fracture	35	37
Foreign Body In Patient	30	30
Impaired Healing	26	27
Swelling/ Edema	23	23
Hypersensitivity/Allergic reaction	22	23
Implant Pain	20	20
Deformity/ Disfigurement	19	19
Joint Dislocation	19	19
Ambulation Difficulties	18	18
Arthritis	15	15
Hematoma	15	15
Thrombosis/Thrombus	15	15
Nerve Damage	15	15
Discomfort	13	13
Inflammation	12	12
Sepsis	11	11
Metal Related Pathology	10	10
Hemorrhage/Bleeding	9	9
Foreign Body Embolism	9	9
Fistula	7	7
Unspecified Heart Problem	7	7
Wound Dehiscence	6	6
Joint Laxity	5	5
Device Embedded In Tissue or Plaque	5	5
Muscular Rigidity	5	5
Bacterial Infection	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Foreign Body Reaction	4	4
Spinal Cord Injury	3	3
Perforation of Vessels	3	3
Fluid Discharge	3	3
Unspecified Musculoskeletal problem	3	3
Skin Inflammation/ Irritation	3	3
Perforation	3	3