TPLC - Total Product Life Cycle

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Device	prosthesis, intervertebral disc
Product Code	MJO
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
21	17	11	12	13	13

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	350	350
Migration	285	285
Insufficient Information	236	236
Patient-Device Incompatibility	186	186
Patient Device Interaction Problem	134	134
Detachment of Device or Device Component	106	106
Migration or Expulsion of Device	85	85
Expulsion	69	69
Collapse	52	52
Osseointegration Problem	49	49
Malposition of Device	46	46
Appropriate Term/Code Not Available	42	44
Fracture	36	36
Loosening of Implant Not Related to Bone-Ingrowth	35	35
Inadequacy of Device Shape and/or Size	26	26
Mechanical Problem	25	25
Biocompatibility	21	21
Device Dislodged or Dislocated	18	18
Unintended Movement	16	16
Break	15	15
Positioning Problem	15	15
Use of Device Problem	15	15
Improper or Incorrect Procedure or Method	14	14
Off-Label Use	12	12
Loss of Osseointegration	10	10
Physical Resistance/Sticking	10	10
Material Fragmentation	9	9
Compatibility Problem	7	7
Failure to Align	7	7
No Apparent Adverse Event	6	6
Failure to Osseointegrate	5	5
Naturally Worn	5	5
Therapeutic or Diagnostic Output Failure	5	6
Noise, Audible	4	4
Unstable	4	4
Material Deformation	4	4
Scratched Material	3	3
Material Twisted/Bent	3	3
Structural Problem	3	3
Mechanics Altered	3	3
Difficult to Remove	3	3
Material Separation	3	3
Crack	3	3
Device-Device Incompatibility	2	2
Material Split, Cut or Torn	2	2
Mechanical Jam	2	2
Entrapment of Device	2	2
Difficult or Delayed Separation	2	2
Human-Device Interface Problem	2	2
Output Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	303	305
Insufficient Information	272	272
No Clinical Signs, Symptoms or Conditions	239	239
Neck Pain	208	208
Osteolysis	166	167
Ossification	106	106
Failure of Implant	103	104
No Code Available	70	70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	63	63
Unspecified Infection	57	57
No Known Impact Or Consequence To Patient	39	39
Numbness	38	38
Implant Pain	38	38
Dysphagia/ Odynophagia	34	34
Inadequate Pain Relief	33	33
Hypersensitivity/Allergic reaction	27	27
Inflammation	25	25
Spinal Column Injury	20	20
Stenosis	20	20
No Information	19	19
Vertebral Fracture	18	18
Muscle Weakness	18	18
Joint Laxity	17	17
Paralysis	16	16
Loss of Range of Motion	15	15
Nerve Damage	14	14
Bone Fracture(s)	14	14
Joint Disorder	13	13
Metal Related Pathology	13	13
Neuropathy	12	12
Patient Problem/Medical Problem	12	12
Headache	12	12
Fall	11	11
Unspecified Musculoskeletal problem	10	10
Foreign Body In Patient	9	9
Unspecified Blood or Lymphatic problem	9	9
Movement Disorder	9	9
No Consequences Or Impact To Patient	9	9
Osteopenia/ Osteoporosis	8	8
Neuralgia	8	8
Paresis	7	7
Peripheral Nervous Injury	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Abscess	7	7
Swelling/ Edema	7	7
Bacterial Infection	7	7
Erosion	7	7
Hemorrhage/Bleeding	7	7
Spinal Cord Injury	7	7
Paresthesia	7	7