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)
2020	2021	2022	2023	2024	2025
2	1	1	1	2	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	775	775
Device Dislodged or Dislocated	81	81
Malposition of Device	68	68
Patient Device Interaction Problem	65	65
Insufficient Information	54	54
Fracture	35	35
Inadequacy of Device Shape and/or Size	30	30
Noise, Audible	29	29
Patient-Device Incompatibility	28	28
Migration	26	26
Loosening of Implant Not Related to Bone-Ingrowth	24	24
Device Appears to Trigger Rejection	23	23
Migration or Expulsion of Device	16	16
Loss of Osseointegration	14	14
Positioning Problem	13	13
No Apparent Adverse Event	9	9
Positioning Failure	7	7
Difficult to Insert	7	7
Fitting Problem	7	7
Material Integrity Problem	6	6
Appropriate Term/Code Not Available	6	6
Installation-Related Problem	5	5
Loose or Intermittent Connection	5	5
Use of Device Problem	4	4
Unintended Movement	4	4
Osseointegration Problem	4	4
Detachment of Device or Device Component	2	2
Nonstandard Device	2	2
Naturally Worn	2	2
Device-Device Incompatibility	2	2
Component Missing	1	1
Contamination	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Handling Problem	1	1
Expiration Date Error	1	1
Activation, Positioning or Separation Problem	1	1
Unstable	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Connection Problem	1	1
Component Incompatible	1	1
Flaked	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pain	341	341
Insufficient Information	181	181
Unspecified Infection	171	171
No Clinical Signs, Symptoms or Conditions	128	128
Loss of Range of Motion	121	121
Joint Dislocation	110	110
Swelling/ Edema	92	92
Failure of Implant	61	61
Ossification	60	60
No Information	60	60
Implant Pain	58	58
Ankylosis	57	57
Bacterial Infection	38	38
Hypersensitivity/Allergic reaction	35	35
Joint Disorder	27	27
Inadequate Pain Relief	22	22
Numbness	21	21
Discomfort	20	20
Difficulty Chewing	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	17	17
Scar Tissue	16	16
Inadequate Osseointegration	15	15
Headache	15	15
Limited Mobility Of The Implanted Joint	14	14
Swelling	14	14
Obstruction/Occlusion	13	13
Nerve Damage	13	13
Deformity/ Disfigurement	12	12
Difficulty Chewing	12	12
Osteolysis	10	10
Hearing Impairment	9	9
Joint Laxity	8	8
Bone Fracture(s)	8	8
Facial Nerve Paralysis	8	8
Cramp(s) /Muscle Spasm(s)	8	8
Itching Sensation	7	7
Bruxism	6	6
Feeding Problem	6	6
Fluid Discharge	6	6
Reaction	6	6
Abscess	6	6
Perforation	5	5
Fistula	5	5
Peripheral Nervous Injury	4	4
Arthritis	4	4
Vertigo	4	4
Increased Sensitivity	4	4
Erythema	4	4
Foreign Body In Patient	4	4
Paresthesia	4	4