TPLC - Total Product Life Cycle

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Device	joint, temporomandibular, implant
Regulation Description	Total temporomandibular joint prosthesis.
Definition	Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Product Code	LZD
Regulation Number	872.3940
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
1	1	1	2	1	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	686	686
Device Dislodged or Dislocated	86	86
Malposition of Device	71	73
Nonstandard Device	67	67
Fracture	53	53
Device Appears to Trigger Rejection	52	52
Insufficient Device Problem Information	48	48
Patient Device Interaction Problem	46	46
Inadequacy of Device Shape and/or Size	39	39
Loosening of Implant Not Related to Bone-Ingrowth	29	29
Noise, Audible	22	22
Patient-Device Incompatibility	21	21
Loss of Osseointegration	19	19
Migration	17	18
Fitting Problem	10	10
No Apparent Adverse Event	10	10
Migration or Expulsion of Device	8	8
Positioning Problem	6	6
Positioning Failure	4	4
Detachment of Device or Device Component	4	4
Unintended Movement	4	4
Osseointegration Problem	3	3
Difficult to Insert	3	3
Use of Device Problem	2	2
Component Incompatible	2	2
Product Quality Problem	2	2
Naturally Worn	2	2
Device-Device Incompatibility	2	2
Connection Problem	1	1
Biocompatibility	1	1
Expiration Date Error	1	1
Use of Incorrect Control/Treatment Settings	1	1
Component Missing	1	1
Material Perforation	1	1
Unstable	1	1
Device Handling Problem	1	1
Contamination	1	1
Flaked	1	1
Improper or Incorrect Procedure or Method	1	1
Installation-Related Problem	1	1
Loose or Intermittent Connection	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	359	361
Insufficient Information	247	247
No Clinical Signs, Symptoms or Conditions	209	210
Unspecified Infection	153	153
Loss of Range of Motion	132	132
Joint Dislocation	122	122
Swelling/ Edema	111	111
Ankylosis	66	66
Failure of Implant	57	57
Implant Pain	56	56
Bacterial Infection	52	52
Extraskeletal ossification	45	45
Hypersensitivity/Allergic reaction	28	28
Difficulty Chewing	22	22
Numbness	20	22
Inadequate Osseointegration	19	19
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	19	19
Obstruction/Occlusion	16	16
Discomfort	15	15
Deformity/ Disfigurement	12	12
Adhesion(s)	12	12
Unspecified Musculoskeletal problem	11	11
Scar Tissue	11	11
Fluid Discharge	10	10
Osteolysis	10	10
Hearing Impairment	9	9
Fistula	9	9
Aseptic loosening	9	9
Headache	9	9
Bone Fracture(s)	8	8
Joint Laxity	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Itching Sensation	7	7
Ear Pain	7	7
Bruxism	6	6
No Information	5	5
Sensitivity of Teeth	5	5
Vertigo	5	5
Metal Related Pathology	4	4
Rheumatoid Arthritis	4	4
Hematoma	4	4
Hyperresponsive to stimuli	4	4
Wound Dehiscence	4	4
Paresthesia	4	4
Limited Mobility Of The Implanted Joint	4	4
Peripheral Nervous Injury	4	4
Perforation	4	4
Speech Disorder	4	4
Abscess	4	4
Foreign Body In Patient	3	3