TPLC - Total Product Life Cycle

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Device	prosthesis, intervertebral disc
Product Code	MJO
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
17	11	12	13	13	6

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	303	304
Migration	262	266
Insufficient Device Problem Information	212	212
Patient-Device Incompatibility	133	133
Patient Device Interaction Problem	97	97
Detachment of Device or Device Component	96	96
Expulsion	65	65
Migration or Expulsion of Device	63	69
Malposition of Device	62	62
Osseointegration Problem	57	57
Collapse	43	43
Fracture	34	34
Mechanical Problem	34	34
Inadequacy of Device Shape and/or Size	25	25
Loosening of Implant Not Related to Bone-Ingrowth	25	25
Biocompatibility	19	25
Device Dislodged or Dislocated	18	18
Positioning Problem	14	14
Use of Device Problem	14	14
Break	13	13
Improper or Incorrect Procedure or Method	13	13
Off-Label Use	11	11
Physical Resistance/Sticking	10	10
Appropriate Device Problem Term/Code Not Available	9	9
Loss of Osseointegration	8	8
Implant subsidence	7	7
Failure to Align	6	6
Failure to Osseointegrate	5	5
Naturally Worn	5	5
Unintended System Motion	4	4
Unintended Movement	4	4
Degraded	4	4
Crack	4	4
No Apparent Adverse Event	4	4
Material Separation	3	3
Material Disintegration	3	3
Scratched Material	2	2
Difficult or Delayed Separation	2	2
Material Deformation	2	2
Human-Device Interface Problem	2	2
Noise, Audible	2	2
Structural Problem	2	2
Material Fragmentation	2	2
Difficult to Remove	2	2
Device-Device Incompatibility	2	2
Material Twisted/Bent	2	2
Mechanical Jam	2	2
Installation-Related Problem	2	2
Lack of Effect	1	1
Mechanics Altered	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	298	298
No Clinical Signs, Symptoms or Conditions	261	261
Pain	261	269
Neck Pain	200	200
Osteolysis	164	165
Failure of Implant	91	100
Extraskeletal ossification	87	87
Unspecified Infection	50	50
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	48	48
Limb Pain	45	45
Inadequate Pain Relief	40	40
Implant Pain	38	38
Numbness	37	37
Dysphagia/ Odynophagia	31	31
Inflammation	25	25
Neuropathy	25	25
Spinal Column Injury	24	24
Hypersensitivity/Allergic reaction	22	22
Stenosis	19	19
Vertebral Fracture	19	19
Bone Fracture(s)	18	18
Joint Laxity	17	17
Muscle Weakness/Atrophy	16	16
Paralysis	14	14
Nerve Damage	12	12
Unspecified Musculoskeletal problem	10	10
Headache	10	10
Loss of Range of Motion	9	9
Fall	9	9
Movement Disorder	9	9
Bacterial Infection	8	8
Paresthesia	8	8
Spinal Cord Injury	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Intervertebral Disc Compression or Protrusion	7	7
Peripheral Nervous Injury	7	7
Hemorrhage/Blood Loss/Bleeding	7	7
Swelling/ Edema	7	7
Dysphasia	6	6
Rash	6	6
Burning Sensation	6	6
Peritonitis	6	6
Dyskinesia	6	6
Multiple Fractures	6	6
Hyporesponsive to stimuli	6	6
Paresis	5	5
Neuralgia	5	5
Fatigue	5	5
Depression	5	7
Cyst(s)	5	5