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	315	315
Migration	262	262
Insufficient Information	220	220
Patient-Device Incompatibility	182	182
Patient Device Interaction Problem	132	132
Detachment of Device or Device Component	91	91
Migration or Expulsion of Device	68	68
Expulsion	57	57
Collapse	45	45
Appropriate Term/Code Not Available	41	41
Malposition of Device	38	38
Osseointegration Problem	38	38
Loosening of Implant Not Related to Bone-Ingrowth	33	33
Fracture	31	31
Inadequacy of Device Shape and/or Size	24	24
Mechanical Problem	24	24
Biocompatibility	19	19
Device Dislodged or Dislocated	17	17
Unintended Movement	16	16
Use of Device Problem	14	14
Positioning Problem	14	14
Break	14	14
Improper or Incorrect Procedure or Method	13	13
Off-Label Use	10	10
Loss of Osseointegration	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
Naturally Worn	5	5
Failure to Osseointegrate	5	5
Unstable	4	4
Material Deformation	4	4
Therapeutic or Diagnostic Output Failure	3	3
Difficult to Remove	3	3
Scratched Material	3	3
Material Twisted/Bent	3	3
Mechanics Altered	3	3
Material Separation	3	3
Human-Device Interface Problem	2	2
Mechanical Jam	2	2
Installation-Related Problem	2	2
Noise, Audible	2	2
Difficult or Delayed Separation	2	2
Structural Problem	2	2
Expiration Date Error	2	2
Material Disintegration	2	2
Output Problem	2	2
Entrapment of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	291	291
Insufficient Information	244	244
No Clinical Signs, Symptoms or Conditions	195	195
Neck Pain	189	189
Osteolysis	151	151
Ossification	100	100
Failure of Implant	99	99
No Code Available	70	70
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	62	62
Unspecified Infection	55	55
No Known Impact Or Consequence To Patient	39	39
Numbness	36	36
Dysphagia/ Odynophagia	33	33
Implant Pain	26	26
Inflammation	24	24
Inadequate Pain Relief	23	23
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