TPLC - Total Product Life Cycle

show TPLC since

Device	condylar plate fixation implant
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	JDP
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	103	119
Adverse Event Without Identified Device or Use Problem	90	91
Device-Device Incompatibility	87	88
Material Twisted/Bent	26	26
Device Slipped	7	7
Material Deformation	6	6
Migration	5	6
Packaging Problem	3	3
Use of Device Problem	2	2
No Apparent Adverse Event	2	2
Fitting Problem	1	1
Crack	1	1
Insufficient Information	1	1
Material Integrity Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	94	95
Non-union Bone Fracture	66	66
No Code Available	36	36
Insufficient Information	34	34
Pain	33	34
Unspecified Infection	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	36
Failure of Implant	17	17
Bone Fracture(s)	15	16
Malunion of Bone	12	12
No Consequences Or Impact To Patient	6	6
Fall	3	4
Unspecified Tissue Injury	3	3
Swelling/ Edema	3	3
Injury	2	2
Thrombosis/Thrombus	2	2
Loss of Range of Motion	2	2
No Patient Involvement	2	2
Physical Asymmetry	2	2
Ambulation Difficulties	2	2
Impaired Healing	1	1
Not Applicable	1	1
Necrosis	1	1
Local Reaction	1	1
Erythema	1	1
Nerve Damage	1	2
Reaction	1	1
Limb Fracture	1	2
Deformity/ Disfigurement	1	1
Arthritis	1	2