TPLC - Total Product Life Cycle

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Device	external mandibular fixator and/or distractor
Regulation Description	Bone plate.
Product Code	MQN
Regulation Number	872.4760
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	102	102
Adverse Event Without Identified Device or Use Problem	100	100
Fracture	30	30
Mechanical Jam	18	18
Osseointegration Problem	18	18
Detachment of Device or Device Component	11	11
Migration	10	10
Device Slipped	8	8
Device-Device Incompatibility	7	7
Difficult to Advance	4	4
Material Separation	4	4
Loss of Osseointegration	4	4
Activation Problem	4	4
Installation-Related Problem	3	3
Use of Device Problem	3	3
Difficult to Remove	2	2
Failure to Deliver	2	2
Entrapment of Device	2	2
Material Deformation	1	1
Material Twisted/Bent	1	1
Misassembly by Users	1	1
Insufficient Device Problem Information	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Activation Failure	1	1
Physical Resistance/Sticking	1	1
Mechanical Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Separation Failure	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	115	115
Insufficient Information	72	72
No Clinical Signs, Symptoms or Conditions	42	42
Unspecified Infection	15	15
Inadequate Osseointegration	13	13
Physical Asymmetry	13	13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Nonunion/Delayed-union Bone Fracture	8	8
Pain	7	7
Post Operative Wound Infection	5	5
Abscess	5	5
Unspecified Tissue Injury	4	4
Blister	4	4
Inflammation	4	4
Bone Fracture(s)	3	3
Foreign Body In Patient	3	3
Discomfort	2	2
Failure of Implant	2	2
Nerve Damage	2	2
Fistula	2	2
Loss of Range of Motion	1	1
Skin Erosion	1	1
Skull Fracture	1	1
Cancer	1	1
Movement Disorder	1	1
Apnea	1	1
Neonatal Deformities	1	1
Granuloma	1	1
Bruxism	1	1
Hemorrhage/Blood Loss/Bleeding	1	1
Deformity/ Disfigurement	1	1
Purulent Discharge	1	1
Necrosis	1	1