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	313	314
Migration	263	267
Insufficient Information	212	212
Patient-Device Incompatibility	136	136
Patient Device Interaction Problem	98	98
Detachment of Device or Device Component	95	95
Expulsion	66	66
Migration or Expulsion of Device	65	71
Malposition of Device	59	59
Osseointegration Problem	56	56
Collapse	45	45
Fracture	34	34
Mechanical Problem	31	31
Inadequacy of Device Shape and/or Size	25	25
Loosening of Implant Not Related to Bone-Ingrowth	25	25
Device Dislodged or Dislocated	20	20
Biocompatibility	19	25
Appropriate Term/Code Not Available	18	20
Break	16	16
Positioning Problem	15	15
Use of Device Problem	15	15
Improper or Incorrect Procedure or Method	14	14
Physical Resistance/Sticking	10	10
Off-Label Use	10	10
Loss of Osseointegration	8	8
Failure to Align	6	6
Naturally Worn	5	5
Therapeutic or Diagnostic Output Failure	5	6
Failure to Osseointegrate	5	5
Unintended Movement	4	4
Unintended System Motion	4	4
Crack	4	4
Degraded	4	4
No Apparent Adverse Event	4	4
Material Disintegration	3	3
Scratched Material	3	3
Material Separation	3	3
Human-Device Interface Problem	2	2
Mechanical Jam	2	2
Installation-Related Problem	2	2
Difficult or Delayed Separation	2	2
Material Deformation	2	2
Noise, Audible	2	2
Mechanics Altered	2	2
Structural Problem	2	2
Material Twisted/Bent	2	2
Material Fragmentation	2	2
Difficult to Remove	2	2
Defective Device	2	2
Expiration Date Error	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	295	295
Pain	259	267
No Clinical Signs, Symptoms or Conditions	257	257
Neck Pain	197	197
Osteolysis	162	163
Failure of Implant	91	100
Ossification	87	87
Unspecified Infection	50	50
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	48	48
Inadequate Pain Relief	40	40
Implant Pain	38	38
Numbness	36	36
Dysphagia/ Odynophagia	31	31
Inflammation	25	25
Neuropathy	24	24
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	15	15
Paralysis	14	14
Nerve Damage	12	12
Headache	10	10
Unspecified Musculoskeletal problem	10	10
Fall	9	9
Loss of Range of Motion	9	9
Movement Disorder	9	9
Paresthesia	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Swelling/ Edema	7	7
Intervertebral Disc Compression or Protrusion	7	7
Peripheral Nervous Injury	7	7
Bacterial Infection	7	7
Hemorrhage/Bleeding	7	7
Spinal Cord Injury	7	7
Peritonitis	6	6
Dysphasia	6	6
Dyskinesia	6	6
Rash	6	6
Decreased Sensitivity	6	6
Burning Sensation	6	6
Multiple Fractures	6	6
Post Operative Wound Infection	5	5
Osteopenia/ Osteoporosis	5	5
Paresis	5	5
Fatigue	5	5
Neuralgia	5	5
Cyst(s)	5	5