TPLC - Total Product Life Cycle

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Device	orthosis, spinal pedicle fixation
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	427	427
Break	205	205
Migration	52	52
Device-Device Incompatibility	51	51
Fracture	47	47
No Apparent Adverse Event	43	43
Device Slipped	38	38
Appropriate Term/Code Not Available	34	34
Material Integrity Problem	34	34
Insufficient Information	29	29
Patient Device Interaction Problem	29	29
Detachment of Device or Device Component	20	20
Compatibility Problem	17	17
Entrapment of Device	16	16
Material Separation	14	14
Loosening of Implant Not Related to Bone-Ingrowth	11	11
Material Twisted/Bent	11	11
Material Deformation	10	10
Mechanical Problem	8	8
Mechanical Jam	6	6
Material Split, Cut or Torn	6	6
Migration or Expulsion of Device	6	6
Device Dislodged or Dislocated	5	5
Unintended Movement	5	5
Material Fragmentation	5	5
Structural Problem	4	4
Patient-Device Incompatibility	4	4
Positioning Problem	3	3
Component or Accessory Incompatibility	3	3
Fitting Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Product Quality Problem	2	2
Use of Device Problem	2	2
Inadequacy of Device Shape and/or Size	2	2
Physical Resistance/Sticking	2	2
Difficult to Remove	2	2
Defective Device	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Loose or Intermittent Connection	2	2
Inadequate or Insufficient Training	1	1
Misassembled	1	1
Calibration Problem	1	1
Solder Joint Fracture	1	1
Misassembly by Users	1	1
Packaging Problem	1	1
Device Damaged by Another Device	1	1
Malposition of Device	1	1
Output Problem	1	1
Crack	1	1
Difficult to Advance	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	197	197
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	112	112
Insufficient Information	100	100
Pain	95	95
Nerve Damage	76	76
Non-union Bone Fracture	75	75
Failure of Implant	74	74
No Code Available	74	74
Post Operative Wound Infection	71	71
No Known Impact Or Consequence To Patient	56	56
Unspecified Infection	53	53
Unspecified Tissue Injury	53	53
Osteolysis	50	50
Bone Fracture(s)	40	40
No Consequences Or Impact To Patient	34	34
Hematoma	33	33
Joint Laxity	31	31
Perforation of Vessels	29	29
Cerebrospinal Fluid Leakage	29	29
Intervertebral Disc Compression or Protrusion	24	24
Physical Asymmetry	22	22
Decreased Sensitivity	20	20
Vertebral Fracture	17	17
Foreign Body In Patient	17	17
No Information	16	16
Spinal Cord Injury	15	15
Impaired Healing	13	13
Limited Mobility Of The Implanted Joint	10	10
Neuralgia	10	10
Injury	9	9
Malunion of Bone	9	9
Joint Disorder	8	8
Neck Pain	8	8
Necrosis	7	7
Implant Pain	7	7
Discomfort	7	7
Thromboembolism	6	6
Loss of Range of Motion	6	6
Device Embedded In Tissue or Plaque	6	6
Hemorrhage/Bleeding	5	5
Not Applicable	5	5
Unspecified Nervous System Problem	5	5
Thrombosis/Thrombus	5	5
Spinal Column Injury	4	4
Neurological Deficit/Dysfunction	3	3
Seroma	3	3
Ambulation Difficulties	3	3
Deformity/ Disfigurement	2	2
Stenosis	2	2
Pulmonary Embolism	2	2