TPLC - Total Product Life Cycle

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Device	orthosis, spondylolisthesis spinal fixation
Regulation Description	Thoracolumbosacral pedicle screw system.
Product Code	MNH
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	786	791
Break	225	225
Migration	187	189
No Apparent Adverse Event	128	128
Loose or Intermittent Connection	107	107
Device Slipped	95	95
Insufficient Information	69	71
Fracture	64	64
Unintended Movement	64	64
Appropriate Term/Code Not Available	53	54
Material Integrity Problem	51	53
Device-Device Incompatibility	48	48
Patient Device Interaction Problem	48	48
Loosening of Implant Not Related to Bone-Ingrowth	39	39
Detachment of Device or Device Component	38	38
Material Twisted/Bent	34	34
Migration or Expulsion of Device	33	33
Material Deformation	33	33
Device Dislodged or Dislocated	28	28
Human-Device Interface Problem	22	22
Mechanical Problem	21	21
Failure to Osseointegrate	20	20
Use of Device Problem	19	19
Material Separation	19	19
Compatibility Problem	12	12
Fluid/Blood Leak	11	11
Entrapment of Device	11	11
Physical Resistance/Sticking	9	9
Material Fragmentation	8	8
Product Quality Problem	8	8
Improper or Incorrect Procedure or Method	5	5
Difficult to Remove	5	5
Improper Chemical Reaction	5	5
Device Handling Problem	5	5
Difficult to Advance	4	4
Mechanical Jam	4	4
Corroded	4	4
Mechanics Altered	4	4
Noise, Audible	3	3
Loss of or Failure to Bond	3	3
Activation, Positioning or Separation Problem	3	3
Inaccurate Information	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Output Problem	2	2
Material Protrusion/Extrusion	2	2
Malposition of Device	2	2
Positioning Failure	2	2
Crack	2	2
Patient-Device Incompatibility	2	2
Positioning Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	401	401
Insufficient Information	353	357
Pain	305	307
No Clinical Signs, Symptoms or Conditions	300	303
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	171	172
Failure of Implant	156	156
Non-union Bone Fracture	127	130
Unspecified Infection	114	115
Bone Fracture(s)	87	89
Nerve Damage	79	82
Injury	74	74
Osteolysis	65	67
Post Operative Wound Infection	64	66
Spinal Column Injury	63	63
No Consequences Or Impact To Patient	61	61
Neurological Deficit/Dysfunction	60	60
Unspecified Tissue Injury	48	50
Hematoma	46	47
Cerebrospinal Fluid Leakage	35	36
Spinal Cord Injury	33	35
Hypoesthesia	30	30
Dysphagia/ Odynophagia	28	28
Impaired Healing	26	27
No Known Impact Or Consequence To Patient	23	23
Inadequate Osseointegration	22	22
Physical Asymmetry	22	22
Paralysis	21	21
Unspecified Nervous System Problem	19	19
No Patient Involvement	17	17
Joint Laxity	16	17
Death	16	16
Foreign Body In Patient	14	14
Perforation of Vessels	12	12
Discomfort	12	12
Hemorrhage/Bleeding	11	11
Wound Dehiscence	11	11
Stenosis	10	11
Numbness	10	11
Fatigue	9	10
Loss of Range of Motion	9	10
Neck Pain	9	11
Seroma	9	9
Deformity/ Disfigurement	9	9
Fall	8	9
Thromboembolism	8	10
Implant Pain	8	8
Decreased Sensitivity	7	8
Necrosis	7	7
Weakness	6	6
Tissue Damage	6	6