TPLC - Total Product Life Cycle

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Device	appliance, fixation, nail/blade/plate combination, single component
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	KTW
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	137	139
Adverse Event Without Identified Device or Use Problem	75	75
Patient Device Interaction Problem	48	48
Failure to Cut	21	22
Entrapment of Device	15	15
Positioning Failure	14	14
Device-Device Incompatibility	10	10
Migration	9	9
Material Deformation	7	7
Material Twisted/Bent	5	5
Physical Resistance/Sticking	4	4
Fitting Problem	3	3
No Apparent Adverse Event	2	2
Insufficient Device Problem Information	2	2
Defective Device	2	2
Use of Device Problem	2	2
Detachment of Device or Device Component	1	1
Device Damaged by Another Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Fracture	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Difficult or Delayed Positioning	1	1
Failure to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	80	83
Failure of Implant	54	54
Pain	40	40
Foreign Body In Patient	36	36
Insufficient Information	36	36
Nonunion/Delayed-union Bone Fracture	34	34
Malunion of Bone	25	25
Unspecified Infection	23	23
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	19
Implant Pain	14	14
Hypersensitivity/Allergic reaction	14	14
Loss of Range of Motion	8	8
Bone Fracture(s)	5	5
Arthritis	4	4
Unspecified Tissue Injury	4	4
Physical Asymmetry	2	2
Necrosis	2	2
Nerve Damage	2	2
Osteolysis	2	2
Post Operative Wound Infection	1	1
Seroma	1	1
Joint Dislocation	1	1
Limb Fracture	1	1