TPLC - Total Product Life Cycle

• Device: condylar plate fixation implant
• Product Code: JDP
• Regulation Number: 888.3030
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	49	49
2020	56	56
2021	79	79
2022	61	61
2023	29	29
2024	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	101	101
Break	92	92
Device-Device Incompatibility	59	59
Material Twisted/Bent	14	14
Migration	7	7
Material Deformation	7	7
Device Slipped	7	7
No Apparent Adverse Event	4	4
Packaging Problem	3	3
Use of Device Problem	3	3
Crack	2	2
Fitting Problem	1	1
Detachment of Device or Device Component	1	1
Insufficient Information	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Non-union Bone Fracture	71	71
No Code Available	69	69
No Clinical Signs, Symptoms or Conditions	55	55
Pain	34	34
Unspecified Infection	29	29
Bone Fracture(s)	22	22
Failure of Implant	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Malunion of Bone	12	12
No Consequences Or Impact To Patient	8	8
Insufficient Information	6	6
No Patient Involvement	4	4
Arthritis	4	4
Injury	3	3
Unspecified Tissue Injury	3	3
Physical Asymmetry	2	2
Thrombosis/Thrombus	2	2
Calcium Deposits/Calcification	2	2
Fall	2	2
Discomfort	2	2
Joint Dislocation	2	2
Osteolysis	2	2
Impaired Healing	2	2
Reaction	1	1
Ambulation Difficulties	1	1
Not Applicable	1	1
Inflammation	1	1
Nerve Damage	1	1
Local Reaction	1	1
Limb Fracture	1	1
Swelling/ Edema	1	1