TPLC - Total Product Life Cycle

• 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	3

MDR Year	MDR Reports	MDR Events
2014	328	328
2015	724	724
2016	161	161
2017	277	277
2018	369	369
2019	380	380
2020	345	345
2021	308	308
2022	265	265
2023	278	278
2024	91	91

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1147	1147
Migration or Expulsion of Device	447	447
Insufficient Information	299	299
Migration	254	254
Patient-Device Incompatibility	226	226
Detachment of Device or Device Component	161	161
Patient Device Interaction Problem	145	145
Appropriate Term/Code Not Available	126	126
Break	108	108
Device Dislodged or Dislocated	107	107
Malposition of Device	94	94
Positioning Problem	72	72
Unintended Movement	61	61
Expulsion	58	58
Collapse	58	58
Material Separation	56	56
Disassembly	54	54
Mechanical Problem	50	50
Improper or Incorrect Procedure or Method	41	41
Fracture	40	40
Inadequacy of Device Shape and/or Size	36	36
Disconnection	35	35
Device Operates Differently Than Expected	34	34
Loosening of Implant Not Related to Bone-Ingrowth	32	32
Device Handling Problem	31	31
Device Slipped	30	30
Loose or Intermittent Connection	28	28
Osseointegration Problem	28	28
Misassembled	27	27
Use of Device Problem	25	25
Mechanical Jam	22	22
Biocompatibility	20	20
Detachment Of Device Component	20	20
Physical Resistance/Sticking	17	17
Material Fragmentation	15	15
Fitting Problem	15	15
No Apparent Adverse Event	13	13
Material Deformation	12	12
Device-Device Incompatibility	12	12
Positioning Failure	12	12
Difficult to Insert	11	11
Failure to Align	11	11
Material Twisted/Bent	11	11
Failure to Osseointegrate	10	10
Unstable	9	9
Device Inoperable	9	9
Off-Label Use	9	9
Difficult to Remove	9	9
Compatibility Problem	9	9
Difficult To Position	8	8
Failure To Adhere Or Bond	8	8
Component Falling	7	7
Loss of Osseointegration	7	7
Failure to Cut	6	6
Sticking	6	6
Metal Shedding Debris	6	6
Component Missing	6	6
Material Disintegration	6	6
Noise, Audible	5	5
Mechanics Altered	5	5
Naturally Worn	5	5
Material Integrity Problem	4	4
Material Split, Cut or Torn	4	4
Entrapment of Device	4	4
Device Operational Issue	4	4
Incomplete or Missing Packaging	3	3
Unintended System Motion	3	3
Device Fell	3	3
Misassembled During Installation	3	3
Installation-Related Problem	3	3
Output Problem	3	3
Packaging Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Misassembly by Users	2	2
Material Protrusion/Extrusion	2	2
Physical Resistance	2	2
Separation Problem	2	2
Peeled/Delaminated	2	2
Sensing Intermittently	2	2
Failure to Sense	2	2
Defective Component	2	2
Defective Device	2	2
Structural Problem	2	2
Failure to Advance	2	2
Failure to Disconnect	2	2
Separation Failure	1	1
Device Packaging Compromised	1	1
Device Sensing Problem	1	1
Blocked Connection	1	1
Deformation Due to Compressive Stress	1	1
Connection Problem	1	1
Activation, Positioning or Separation Problem	1	1
Microbial Contamination of Device	1	1
Material Perforation	1	1
Device Issue	1	1
Dull, Blunt	1	1
Unraveled Material	1	1
Shelf Life Exceeded	1	1
Material Rupture	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	868	868
No Code Available	680	680
No Known Impact Or Consequence To Patient	454	455
Failure of Implant	383	384
Neck Pain	328	328
No Consequences Or Impact To Patient	219	219
Ossification	217	217
Insufficient Information	198	198
No Clinical Signs, Symptoms or Conditions	143	143
Impaired Healing	126	126
Osteolysis	121	121
No Information	117	117
Loss of Range of Motion	83	83
Numbness	79	79
Unspecified Infection	70	70
Bone Fracture(s)	63	63
Dysphagia/ Odynophagia	62	62
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	55	55
Stenosis	54	54
Nerve Damage	52	52
Neuropathy	48	48
Inflammation	38	38
Patient Problem/Medical Problem	33	33
Discomfort	32	32
Reaction	32	32
Weakness	31	31
Neurological Deficit/Dysfunction	30	30
Injury	28	28
Hypersensitivity/Allergic reaction	27	27
Muscle Weakness	26	26
Headache	25	25
Tingling	25	25
Fall	23	23
Arthritis	22	22
Spinal Column Injury	22	22
Hematoma	21	21
Inadequate Pain Relief	21	21
Paralysis	17	17
Joint Disorder	16	16
Post Operative Wound Infection	16	16
Joint Laxity	16	16
Vertebral Fracture	15	15
Foreign Body In Patient	15	15
Limited Mobility Of The Implanted Joint	15	15
Device Embedded In Tissue or Plaque	15	15
Neck Stiffness	15	15
Abscess	14	14
Metal Related Pathology	12	12
Implant Pain	12	12
Bacterial Infection	11	11
Rash	11	11
Muscle Spasm(s)	11	11
Non-union Bone Fracture	11	11
Complaint, Ill-Defined	11	11
Spinal Cord Injury	10	10
Cyst(s)	10	10
Laceration(s)	9	9
Hemorrhage/Bleeding	9	9
Swelling	9	9
No Patient Involvement	9	9
Disability	9	9
Hernia	9	9
Tissue Damage	9	9
Unspecified Blood or Lymphatic problem	9	9
Neuralgia	8	8
Dysphasia	8	8
Joint Dislocation	8	8
Inadequate Osseointegration	8	8
Ambulation Difficulties	8	8
Nausea	8	8
Paresis	8	8
Undesired Nerve Stimulation	8	8
Fatigue	8	8
Cerebrospinal Fluid Leakage	7	7
Irritation	7	7
Scar Tissue	7	7
Quadriplegia	7	7
Cramp(s) /Muscle Spasm(s)	7	7
Decreased Sensitivity	7	7
Constipation	6	6
Intervertebral Disc Compression or Protrusion	6	6
Peripheral Nervous Injury	6	6
Osteopenia/ Osteoporosis	6	6
Disc Impingement	6	6
Sedation	6	6
Dyskinesia	6	6
Burning Sensation	6	6
Peritonitis	6	6
Hypoesthesia	6	6
Death	6	6
Wound Dehiscence	6	6
Abdominal Pain	5	5
Erosion	5	5
Erythema	5	5
Fever	5	5
Apnea	5	5
Dizziness	5	5
Thrombosis	5	5
Paresthesia	5	5
Paraplegia	5	5

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