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	604	604
Break	162	162
Migration	145	145
Loose or Intermittent Connection	106	106
Device Slipped	74	74
No Apparent Adverse Event	62	62
Insufficient Information	52	52
Unintended Movement	52	52
Appropriate Term/Code Not Available	51	51
Fracture	48	48
Material Integrity Problem	45	45
Device-Device Incompatibility	45	45
Patient Device Interaction Problem	39	39
Loosening of Implant Not Related to Bone-Ingrowth	37	37
Material Twisted/Bent	33	33
Detachment of Device or Device Component	32	32
Migration or Expulsion of Device	31	31
Material Deformation	30	30
Device Dislodged or Dislocated	27	27
Human-Device Interface Problem	19	19
Use of Device Problem	19	19
Material Separation	19	19
Mechanical Problem	17	17
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 Chemical Reaction	5	5
Device Handling Problem	5	5
Difficult to Advance	4	4
Difficult to Remove	4	4
Mechanics Altered	4	4
Noise, Audible	3	3
Loss of or Failure to Bond	3	3
Improper or Incorrect Procedure or Method	3	3
Activation, Positioning or Separation Problem	3	3
Inaccurate Information	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Mechanical Jam	2	2
Material Protrusion/Extrusion	2	2
Positioning Failure	2	2
Positioning Problem	2	2
Malposition of Device	2	2
Output Problem	2	2
Inflation Problem	1	1
Component Missing	1	1
Difficult to Insert	1	1
Expulsion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	345	345
No Clinical Signs, Symptoms or Conditions	285	285
Pain	201	201
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	173	173
No Code Available	155	155
Failure of Implant	142	142
Non-union Bone Fracture	94	94
Injury	70	70
Post Operative Wound Infection	68	68
Bone Fracture(s)	67	67
Unspecified Infection	65	65
Nerve Damage	62	62
Osteolysis	60	60
Unspecified Tissue Injury	53	53
Spinal Column Injury	53	53
No Consequences Or Impact To Patient	51	51
Hematoma	44	44
Neurological Deficit/Dysfunction	39	39
Spinal Cord Injury	30	30
Cerebrospinal Fluid Leakage	29	29
Dysphagia/ Odynophagia	26	26
Hypoesthesia	23	23
Physical Asymmetry	22	22
Unspecified Nervous System Problem	19	19
Paralysis	19	19
Joint Laxity	17	17
Death	16	16
Foreign Body In Patient	14	14
Impaired Healing	13	13
No Patient Involvement	12	12
Perforation of Vessels	11	11
Hemorrhage/Bleeding	10	10
No Known Impact Or Consequence To Patient	10	10
Deformity/ Disfigurement	9	9
Discomfort	9	9
Neck Pain	9	9
Fall	8	8
Numbness	8	8
Decreased Sensitivity	8	8
Thromboembolism	8	8
Fatigue	7	7
Wound Dehiscence	7	7
Loss of Range of Motion	6	6
Implant Pain	6	6
Stenosis	5	5
Tissue Damage	5	5
Muscular Rigidity	5	5
Hypersensitivity/Allergic reaction	4	4
Speech Disorder	3	3
Device Embedded In Tissue or Plaque	3	3