TPLC - Total Product Life Cycle

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Device	appliance, fixation, nail/blade/plate combination, single component
Product Code	KTW
Regulation Number	888.3030
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADVANCED ORTHOPAEDIC SOLUTIONS, INC
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	1
PAONAN BIOTECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	147	147
Break	117	117
Device-Device Incompatibility	16	16
Patient Device Interaction Problem	16	16
Migration or Expulsion of Device	15	15
Failure to Cut	14	14
Fracture	13	13
Fitting Problem	9	9
Material Twisted/Bent	9	9
Device Operates Differently Than Expected	7	7
Migration	7	7
Material Deformation	7	7
Appropriate Term/Code Not Available	5	5
Unintended Movement	4	4
Failure to Power Up	3	3
Sticking	2	2
Device Dislodged or Dislocated	2	2
Mechanical Jam	2	2
Entrapment of Device	2	2
Deformation Due to Compressive Stress	2	2
Detachment of Device or Device Component	2	2
No Apparent Adverse Event	2	2
Insufficient Information	1	1
Dull, Blunt	1	1
Failure to Align	1	1
Failure to Disconnect	1	1
Operating System Becomes Nonfunctional	1	1
Positioning Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Damaged by Another Device	1	1
Use of Device Problem	1	1
Metal Shedding Debris	1	1
Failure to Osseointegrate	1	1
Difficult to Remove	1	1
Device Slipped	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Crack	1	1
Difficult or Delayed Positioning	1	1
Failure To Adhere Or Bond	1	1
Bent	1	1
Partial Blockage	1	1
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Failure of Implant	82	82
Pain	59	59
Non-union Bone Fracture	54	54
No Code Available	47	47
Impaired Healing	33	33
Insufficient Information	32	32
No Clinical Signs, Symptoms or Conditions	32	32
No Known Impact Or Consequence To Patient	28	28
Unspecified Infection	26	26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Hypersensitivity/Allergic reaction	14	14
Loss of Range of Motion	11	11
Bone Fracture(s)	10	10
Necrosis	10	10
Malunion of Bone	9	9
Unspecified Tissue Injury	4	4
Fall	4	4
Arthritis	4	4
No Consequences Or Impact To Patient	4	4
Nerve Damage	3	3
Post Operative Wound Infection	3	3
Ambulation Difficulties	2	2
Not Applicable	2	2
No Information	2	2
Reaction	2	2
Fracture, Arm	2	2
Swelling	2	2
Osteolysis	2	2
Irritation	2	2
Physical Asymmetry	2	2
Swelling/ Edema	1	1
Implant Pain	1	1
Limb Fracture	1	1
Inflammation	1	1
Erosion	1	1
Discomfort	1	1
Injury	1	1
Hip Fracture	1	1
Seizures	1	1
Seroma	1	1
Skin Erosion	1	1
Spinal Column Injury	1	1
Joint Dislocation	1	1
Sedation	1	1
No Patient Involvement	1	1
Foreign Body In Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Synthes USA (HQ), Inc.	II	Feb-16-2011