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	254	254
Adverse Event Without Identified Device or Use Problem	229	229
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
Device Slipped	7	7
Detachment of Device or Device Component	7	7
Migration	7	7
Fitting Problem	6	6
Loose or Intermittent Connection	6	6
Failure To Adhere Or Bond	5	5
Insufficient Information	4	4
No Apparent Adverse Event	4	4
Crack	3	3
Use of Device Problem	3	3
Packaging Problem	3	3
Malposition of Device	2	2
Fracture	2	2
Device Operates Differently Than Expected	2	2
Device Dislodged or Dislocated	2	2
Appropriate Term/Code Not Available	2	2
Corroded	2	2
Component or Accessory Incompatibility	1	1
Operating System Becomes Nonfunctional	1	1
Mechanical Problem	1	1
Material Integrity Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Failure to Capture	1	1
Difficult To Position	1	1
Device Contamination with Chemical or Other Material	1	1
Device Inoperable	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Non-union Bone Fracture	198	198
Failure of Implant	186	186
No Code Available	151	151
Pain	76	76
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
Insufficient Information	16	16
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
Hip Fracture	6	6
Limited Mobility Of The Implanted Joint	6	6
Swelling	5	5
No Patient Involvement	5	5
Arthritis	4	4
Device Embedded In Tissue or Plaque	3	3
No Information	3	3
Unspecified Tissue Injury	3	3
Irritation	3	3
Injury	3	3
Sedation	3	3
Ambulation Difficulties	2	2
Physical Asymmetry	2	2
Swelling/ Edema	2	2
Calcium Deposits/Calcification	2	2
Osteolysis	2	2
Loss of Range of Motion	2	2
Thrombosis/Thrombus	2	2
Not Applicable	2	2
Joint Dislocation	2	2
Death	2	2
Nerve Damage	1	1
Limb Fracture	1	1
Post Operative Wound Infection	1	1
Local Reaction	1	1
Dysphagia/ Odynophagia	1	1
Ischemia	1	1
Inflammation	1	1
Deformity/ Disfigurement	1	1