TPLC - Total Product Life Cycle

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Device	prosthesis, intervertebral disc
Product Code	MJO
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
1	6	11	6	12	25	11	14	15	9	12	21	17	11	12	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1169	1169
Migration or Expulsion of Device	450	450
Insufficient Information	324	324
Migration	288	288
Patient-Device Incompatibility	233	233
Detachment of Device or Device Component	168	168
Patient Device Interaction Problem	149	149
Appropriate Term/Code Not Available	127	127
Break	108	108
Device Dislodged or Dislocated	108	108
Malposition of Device	96	96
Positioning Problem	73	73
Collapse	64	64
Expulsion	61	61
Unintended Movement	61	61
Material Separation	56	56
Disassembly	54	54
Mechanical Problem	51	51
Fracture	44	44
Improper or Incorrect Procedure or Method	43	43
Inadequacy of Device Shape and/or Size	37	37
Loosening of Implant Not Related to Bone-Ingrowth	36	36
Disconnection	35	35
Device Operates Differently Than Expected	34	34
Osseointegration Problem	33	33
Device Handling Problem	31	31
Device Slipped	30	30
Loose or Intermittent Connection	28	28
Misassembled	27	27
Use of Device Problem	26	26
Mechanical Jam	22	22
Detachment Of Device Component	20	20
Biocompatibility	20	20
Physical Resistance/Sticking	18	18
Material Fragmentation	15	15
Fitting Problem	15	15
Device-Device Incompatibility	14	14
No Apparent Adverse Event	13	13
Positioning Failure	12	12
Material Deformation	12	12
Difficult to Insert	11	11
Material Twisted/Bent	11	11
Failure to Align	11	11
Failure to Osseointegrate	10	10
Difficult to Remove	10	10
Off-Label Use	10	10
Device Inoperable	9	9
Loss of Osseointegration	9	9
Compatibility Problem	9	9
Unstable	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	897	897
No Code Available	680	680
No Known Impact Or Consequence To Patient	454	455
Failure of Implant	398	399
Neck Pain	353	353
Ossification	222	222
Insufficient Information	221	221
No Consequences Or Impact To Patient	219	219
No Clinical Signs, Symptoms or Conditions	161	161
Osteolysis	145	145
Impaired Healing	126	126
No Information	117	117
Numbness	90	90
Loss of Range of Motion	85	85
Unspecified Infection	76	76
Bone Fracture(s)	64	64
Dysphagia/ Odynophagia	63	63
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	59	59
Stenosis	56	56
Nerve Damage	53	53
Neuropathy	48	48
Inflammation	41	41
Patient Problem/Medical Problem	33	33
Discomfort	32	32
Reaction	32	32
Weakness	31	31
Neurological Deficit/Dysfunction	30	30
Muscle Weakness	28	28
Injury	28	28
Headache	28	28
Hypersensitivity/Allergic reaction	27	27
Tingling	25	25
Fall	23	23
Spinal Column Injury	23	23
Inadequate Pain Relief	22	22
Arthritis	22	22
Hematoma	21	21
Paralysis	18	18
Implant Pain	18	18
Joint Laxity	17	17
Vertebral Fracture	17	17
Joint Disorder	16	16
Post Operative Wound Infection	16	16
Limited Mobility Of The Implanted Joint	15	15
Neck Stiffness	15	15
Foreign Body In Patient	15	15
Device Embedded In Tissue or Plaque	15	15
Abscess	14	14
Bacterial Infection	13	13
Metal Related Pathology	12	12

Recalls
Manufacturer		Recall Class	Date Posted
1	Centinel Spine, Inc.	II	Apr-09-2021
2	Medicrea International	II	Aug-24-2023
3	Medtronic Sofamor Danek USA Inc	II	May-04-2018
4	NuVasive Inc	II	Jul-22-2022