TPLC - Total Product Life Cycle

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Device	orthosis, spinal pedicle fixation
Regulation Description	Thoracolumbosacral pedicle screw system.
Product Code	MNI
Regulation Number	888.3070
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	372	379
Break	157	160
Fracture	50	52
Device-Device Incompatibility	39	40
Device Slipped	34	39
Migration	32	32
Appropriate Term/Code Not Available	26	26
Patient Device Interaction Problem	22	22
Insufficient Information	21	21
No Apparent Adverse Event	18	18
Compatibility Problem	17	17
Material Integrity Problem	17	17
Detachment of Device or Device Component	15	16
Entrapment of Device	15	15
Patient-Device Incompatibility	14	14
Loosening of Implant Not Related to Bone-Ingrowth	9	9
Material Twisted/Bent	7	7
Mechanical Problem	6	7
Material Fragmentation	5	5
Material Deformation	4	4
Material Split, Cut or Torn	3	3
Difficult to Advance	2	2
Loose or Intermittent Connection	2	2
Malposition of Device	2	2
Loss of or Failure to Bond	1	1
Deformation Due to Compressive Stress	1	1
Failure to Osseointegrate	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Separation Failure	1	1
Defective Device	1	1
Migration or Expulsion of Device	1	1
Device Appears to Trigger Rejection	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Dislodged or Dislocated	1	1
Device Damaged by Another Device	1	1
Mechanical Jam	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	228	230
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	113	113
Insufficient Information	98	103
Non-union Bone Fracture	73	73
Pain	71	75
Post Operative Wound Infection	70	71
Failure of Implant	65	68
Nerve Damage	60	60
Unspecified Tissue Injury	47	47
Osteolysis	45	45
Unspecified Infection	42	42
Bone Fracture(s)	35	35
Joint Laxity	33	33
Hematoma	29	29
Cerebrospinal Fluid Leakage	29	29
Perforation of Vessels	29	29
Intervertebral Disc Compression or Protrusion	26	26
Physical Asymmetry	22	28
Decreased Sensitivity	20	20
Vertebral Fracture	17	17
Spinal Cord Injury	17	17
Neck Pain	11	11
Foreign Body In Patient	11	11
Neuralgia	10	10
Malunion of Bone	9	9
Stenosis	8	8
Impaired Healing	7	8
Implant Pain	7	9
Thromboembolism	6	6
Loss of Range of Motion	6	6
Ambulation Difficulties	5	5
Necrosis	5	5
Unspecified Nervous System Problem	5	5
Thrombosis/Thrombus	5	5
Discomfort	5	5
Hemorrhage/Bleeding	3	3
Burning Sensation	3	3
Numbness	3	3
Deformity/ Disfigurement	2	2
Unspecified Kidney or Urinary Problem	2	2
Muscular Rigidity	2	2
Seroma	2	2
Osteopenia/ Osteoporosis	2	2
Embolism/Embolus	2	2
Synovitis	2	3
Inadequate Osseointegration	2	2
Fatigue	2	2
Hypersensitivity/Allergic reaction	2	2
Wound Dehiscence	2	2
Rash	1	1