TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	243	243
Adverse Event Without Identified Device or Use Problem	228	228
Device-Device Incompatibility	64	64
Unintended Movement	35	35
Migration or Expulsion of Device	15	15
Material Twisted/Bent	14	14
Bent	10	10
Material Deformation	9	9
Detachment of Device or Device Component	7	7
Migration	7	7
Device Slipped	7	7
Fitting Problem	6	6
Loose or Intermittent Connection	6	6
Failure To Adhere Or Bond	5	5
No Apparent Adverse Event	4	4
Insufficient Information	4	4
Packaging Problem	3	3
Crack	3	3
Use of Device Problem	3	3
Corroded	2	2
Malposition of Device	2	2
Fracture	2	2
Appropriate Term/Code Not Available	2	2
Device Operates Differently Than Expected	2	2
Device Dislodged or Dislocated	2	2
Device Contamination with Chemical or Other Material	1	1
Material Integrity Problem	1	1
Mechanical Jam	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Operating System Becomes Nonfunctional	1	1
Mechanical Problem	1	1
Failure to Capture	1	1
Component or Accessory Incompatibility	1	1
Device Inoperable	1	1
Difficult To Position	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Non-union Bone Fracture	196	196
Failure of Implant	186	186
No Code Available	151	151
Pain	75	75
Unspecified Infection	64	64
No Clinical Signs, Symptoms or Conditions	55	55
Impaired Healing	54	54
Bone Fracture(s)	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	21	21
Fall	17	17
No Consequences Or Impact To Patient	12	12
Malunion of Bone	12	12
Discomfort	9	9
Reaction	9	9
No Known Impact Or Consequence To Patient	8	8
Burn(s)	8	8
Wound Dehiscence	6	6
Limited Mobility Of The Implanted Joint	6	6
Hip Fracture	6	6
Insufficient Information	6	6
Swelling	5	5
No Patient Involvement	5	5
Arthritis	4	4
Injury	3	3
Irritation	3	3
Device Embedded In Tissue or Plaque	3	3
No Information	3	3
Sedation	3	3
Unspecified Tissue Injury	3	3
Physical Asymmetry	2	2
Joint Dislocation	2	2
Osteolysis	2	2
Thrombosis/Thrombus	2	2
Not Applicable	2	2
Calcium Deposits/Calcification	2	2
Death	2	2
Dysphagia/ Odynophagia	1	1
Ischemia	1	1
Nerve Damage	1	1
Inflammation	1	1
Loss of Range of Motion	1	1
Local Reaction	1	1
Limb Fracture	1	1
Post Operative Wound Infection	1	1
Ambulation Difficulties	1	1
Swelling/ Edema	1	1