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	103	103
Adverse Event Without Identified Device or Use Problem	95	95
Fracture	21	21
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
Activation Problem	4	4
Material Separation	4	4
Loss of Osseointegration	4	4
Use of Device Problem	3	3
Installation-Related Problem	3	3
Entrapment of Device	2	2
Difficult to Advance	2	2
Mechanical Problem	1	1
Physical Resistance/Sticking	1	1
Separation Failure	1	1
Insufficient Information	1	1
Difficult to Remove	1	1
Material Twisted/Bent	1	1
Material Deformation	1	1
Activation Failure	1	1
Appropriate Term/Code Not Available	1	1
Premature Separation	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Impaired Healing	115	115
Insufficient Information	52	52
No Clinical Signs, Symptoms or Conditions	38	38
Unspecified Infection	15	15
Inadequate Osseointegration	13	13
Physical Asymmetry	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Non-union Bone Fracture	8	8
Pain	7	7
Inflammation	4	4
Blister	4	4
Post Operative Wound Infection	4	4
Abscess	4	4
Unspecified Tissue Injury	4	4
Bone Fracture(s)	3	3
Foreign Body In Patient	3	3
Failure of Implant	2	2
Nerve Damage	2	2
Discomfort	2	2
Fistula	2	2
Apnea	1	1
Necrosis	1	1
Neonatal Deformities	1	1
Skull Fracture	1	1
Purulent Discharge	1	1
Movement Disorder	1	1
Skin Erosion	1	1
Loss of Range of Motion	1	1
Bruxism	1	1
Hemorrhage/Bleeding	1	1
Deformity/ Disfigurement	1	1
Cancer	1	1