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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	329	329
Migration	267	267
Insufficient Information	225	225
Patient-Device Incompatibility	182	182
Patient Device Interaction Problem	132	132
Detachment of Device or Device Component	95	95
Migration or Expulsion of Device	68	68
Expulsion	63	63
Collapse	47	47
Appropriate Term/Code Not Available	41	41
Malposition of Device	40	40
Osseointegration Problem	39	39
Loosening of Implant Not Related to Bone-Ingrowth	33	33
Fracture	32	32
Mechanical Problem	25	25
Inadequacy of Device Shape and/or Size	24	24
Biocompatibility	19	19
Device Dislodged or Dislocated	17	17
Unintended Movement	16	16
Positioning Problem	14	14
Use of Device Problem	14	14
Break	14	14
Improper or Incorrect Procedure or Method	13	13
Loss of Osseointegration	10	10
Off-Label Use	10	10
Material Fragmentation	9	9
Physical Resistance/Sticking	9	9
Failure to Align	7	7
Compatibility Problem	7	7
No Apparent Adverse Event	6	6
Therapeutic or Diagnostic Output Failure	5	5
Failure to Osseointegrate	5	5
Naturally Worn	5	5
Noise, Audible	4	4
Material Deformation	4	4
Unstable	4	4
Difficult to Remove	3	3
Scratched Material	3	3
Material Twisted/Bent	3	3
Structural Problem	3	3
Mechanics Altered	3	3
Material Separation	3	3
Expiration Date Error	2	2
Material Disintegration	2	2
Crack	2	2
Output Problem	2	2
Mechanical Jam	2	2
Difficult or Delayed Separation	2	2
Entrapment of Device	2	2
Installation-Related Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	295	295
Insufficient Information	255	255
No Clinical Signs, Symptoms or Conditions	208	208
Neck Pain	197	197
Osteolysis	156	156
Ossification	105	105
Failure of Implant	102	102
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
Dysphagia/ Odynophagia	33	33
Inadequate Pain Relief	27	27
Implant Pain	26	26
Inflammation	24	24
Hypersensitivity/Allergic reaction	21	21
Stenosis	20	20
Spinal Column Injury	20	20
No Information	19	19
Vertebral Fracture	18	18
Muscle Weakness	18	18
Joint Laxity	17	17
Loss of Range of Motion	15	15
Bone Fracture(s)	14	14
Nerve Damage	14	14
Paralysis	14	14
Metal Related Pathology	13	13
Joint Disorder	13	13
Neuropathy	12	12
Patient Problem/Medical Problem	12	12
Fall	11	11
Unspecified Musculoskeletal problem	10	10
Foreign Body In Patient	9	9
No Consequences Or Impact To Patient	9	9
Unspecified Blood or Lymphatic problem	9	9
Headache	8	8
Neuralgia	8	8
Spinal Cord Injury	7	7
Abscess	7	7
Paresis	7	7
Bacterial Infection	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Erosion	7	7
Hemorrhage/Bleeding	7	7
Ambulation Difficulties	6	6
Peripheral Nervous Injury	6	6
Dysphasia	6	6
Joint Dislocation	6	6
Decreased Sensitivity	6	6