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	135	137
Adverse Event Without Identified Device or Use Problem	76	76
Patient Device Interaction Problem	48	48
Failure to Cut	20	21
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 Information	2	2
Fracture	2	2
Use of Device Problem	2	2
Defective Device	2	2
Detachment of Device or Device Component	1	1
Device Damaged by Another Device	1	1
Difficult or Delayed Positioning	1	1
Appropriate Term/Code Not Available	1	1
Failure to Advance	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	77	80
Failure of Implant	54	54
Pain	40	40
Foreign Body In Patient	36	36
Insufficient Information	36	36
Non-union Bone Fracture	34	34
Malunion of Bone	25	25
Unspecified Infection	23	23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	19	19
Hypersensitivity/Allergic reaction	14	14
Implant Pain	14	14
Loss of Range of Motion	8	8
Bone Fracture(s)	5	5
Unspecified Tissue Injury	4	4
Arthritis	4	4
Necrosis	2	2
Nerve Damage	2	2
Osteolysis	2	2
Physical Asymmetry	2	2
Joint Dislocation	1	1
Post Operative Wound Infection	1	1
Seroma	1	1
Limb Fracture	1	1